RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>71209-052-17</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (71209-052-17)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>71209-0052-17</NDC11Code>
    <ProductNDC>71209-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208606</ApplicationNumber>
    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Bupropion hydrochloride, USP an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride tablets, USP are supplied for oral administration as 75 mg (yellow) and 100 mg (maroon) film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: 75 mg tablet – colloidal silicone dioxide, crospovidone, D&amp;C yellow No.10, FD&amp;C yellow No.6, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide; 100 mg tablet – colloidal silicone dioxide, crospovidone, D&amp;C yellow No.10, FD&amp;C red No.40, FD&amp;C yellow No.6, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71209-053-17</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (71209-053-17)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>71209-0053-17</NDC11Code>
    <ProductNDC>71209-053</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208606</ApplicationNumber>
    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Bupropion hydrochloride, USP an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride tablets, USP are supplied for oral administration as 75 mg (yellow) and 100 mg (maroon) film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: 75 mg tablet – colloidal silicone dioxide, crospovidone, D&amp;C yellow No.10, FD&amp;C yellow No.6, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide; 100 mg tablet – colloidal silicone dioxide, crospovidone, D&amp;C yellow No.10, FD&amp;C red No.40, FD&amp;C yellow No.6, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71209-052-05</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (71209-052-05) </PackageDescription>
    <NDC11Code>71209-0052-05</NDC11Code>
    <ProductNDC>71209-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208606</ApplicationNumber>
    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Bupropion hydrochloride, USP an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride tablets, USP are supplied for oral administration as 75 mg (yellow) and 100 mg (maroon) film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: 75 mg tablet – colloidal silicone dioxide, crospovidone, D&amp;C yellow No.10, FD&amp;C yellow No.6, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide; 100 mg tablet – colloidal silicone dioxide, crospovidone, D&amp;C yellow No.10, FD&amp;C red No.40, FD&amp;C yellow No.6, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71209-052-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (71209-052-11) </PackageDescription>
    <NDC11Code>71209-0052-11</NDC11Code>
    <ProductNDC>71209-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208606</ApplicationNumber>
    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Bupropion hydrochloride, USP an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride tablets, USP are supplied for oral administration as 75 mg (yellow) and 100 mg (maroon) film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: 75 mg tablet – colloidal silicone dioxide, crospovidone, D&amp;C yellow No.10, FD&amp;C yellow No.6, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide; 100 mg tablet – colloidal silicone dioxide, crospovidone, D&amp;C yellow No.10, FD&amp;C red No.40, FD&amp;C yellow No.6, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>10695-052-17</NDCCode>
    <PackageDescription>.5 kg in 1 BOTTLE (10695-052-17) </PackageDescription>
    <NDC11Code>10695-0052-17</NDC11Code>
    <ProductNDC>10695-052</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Ivermectin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190311</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Willow Birch Pharma, Inc.</LabelerName>
    <SubstanceName>IVERMECTIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-11-27</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-MAR-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>42086-052-02</NDCCode>
    <PackageDescription>720 TUBE in 1 PACKAGE (42086-052-02)  / 17 g in 1 TUBE</PackageDescription>
    <NDC11Code>42086-0052-02</NDC11Code>
    <ProductNDC>42086-052</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Charm Tex Fluoride Gel</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20260531</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Jiangsu Gold Worldworks Household Chemicals Co., Ltd.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Help protect against cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43473-052-01</NDCCode>
    <PackageDescription>17.5 mL in 1 BOTTLE (43473-052-01) </PackageDescription>
    <NDC11Code>43473-0052-01</NDC11Code>
    <ProductNDC>43473-052</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cotton On Foundation Coastal Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240904</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Nantong Health &amp; Beyond Hygienic Products Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240904</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 Hand sanitizer to help reduce baterial on the skin that could cause diseases.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69618-052-77</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (69618-052-77)  / 17 g in 1 TUBE</PackageDescription>
    <NDC11Code>69618-0052-77</NDC11Code>
    <ProductNDC>69618-052</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Boroleum</ProprietaryName>
    <NonProprietaryName>Camphor, Menthol, White Petrolatum</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190416</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Reliable 1 Laboratories</LabelerName>
    <SubstanceName>WHITE PETROLATUM; CAMPHOR (SYNTHETIC); MENTHOL</SubstanceName>
    <StrengthNumber>97.92; 1; .54</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190416</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain and itching associated with minor cuts, scrapes, insect bites, and minor skin irritations (e.g. chafed nose). Temporarily protects minor cuts and scrapes. Helps prevent, relieve, and temporarily protect chafed, chapped, or cracked skin and lips. Helps prevent and protect from the drying effects of wind and cold weather.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75749-052-17</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, SPRAY (75749-052-17) </PackageDescription>
    <NDC11Code>75749-0052-17</NDC11Code>
    <ProductNDC>75749-052</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201102</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>NINGBO PRETTY TOURISM MANUFACTURE CO.,LTD.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71209-040-01</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (71209-040-01) </PackageDescription>
    <NDC11Code>71209-0040-01</NDC11Code>
    <ProductNDC>71209-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206993</ApplicationNumber>
    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2 )].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3 )].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4 )]. Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of  C17 H18 F3 NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine.  The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, sodium lauryl sulphate, titanium dioxide, iron oxide yellow, FD&amp;C Blue No.1. In addition 40 mg also contains FD&amp;C Yellow No.6. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>71209-040-05</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (71209-040-05) </PackageDescription>
    <NDC11Code>71209-0040-05</NDC11Code>
    <ProductNDC>71209-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
    <NonProprietaryName>Fluoxetine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206993</ApplicationNumber>
    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2 )].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3 )].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4 )]. Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of  C17 H18 F3 NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine.  The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, sodium lauryl sulphate, titanium dioxide, iron oxide yellow, FD&amp;C Blue No.1. In addition 40 mg also contains FD&amp;C Yellow No.6. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2 )].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3 )].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4 )]. Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of  C17 H18 F3 NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine.  The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, sodium lauryl sulphate, titanium dioxide, iron oxide yellow, FD&amp;C Blue No.1. In addition 40 mg also contains FD&amp;C Yellow No.6. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2 )].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3 )].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4 )]. Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of  C17 H18 F3 NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine.  The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, sodium lauryl sulphate, titanium dioxide, iron oxide yellow, FD&amp;C Blue No.1. In addition 40 mg also contains FD&amp;C Yellow No.6. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2 )].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3 )].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4 )]. Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of  C17 H18 F3 NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine.  The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, sodium lauryl sulphate, titanium dioxide, iron oxide yellow, FD&amp;C Blue No.1. In addition 40 mg also contains FD&amp;C Yellow No.6. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2 )].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3 )].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4 )]. Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of  C17 H18 F3 NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine.  The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, sodium lauryl sulphate, titanium dioxide, iron oxide yellow, FD&amp;C Blue No.1. In addition 40 mg also contains FD&amp;C Yellow No.6. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2 )].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3 )].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4 )]. Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of  C17 H18 F3 NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine.  The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, sodium lauryl sulphate, titanium dioxide, iron oxide yellow, FD&amp;C Blue No.1. In addition 40 mg also contains FD&amp;C Yellow No.6. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2 )].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3 )].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4 )]. Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of  C17 H18 F3 NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine.  The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, sodium lauryl sulphate, titanium dioxide, iron oxide yellow, FD&amp;C Blue No.1. In addition 40 mg also contains FD&amp;C Yellow No.6. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2 )].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3 )].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4 )]. Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of  C17 H18 F3 NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine.  The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, sodium lauryl sulphate, titanium dioxide, iron oxide yellow, FD&amp;C Blue No.1. In addition 40 mg also contains FD&amp;C Yellow No.6. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2 )].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3 )].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4 )]. Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of  C17 H18 F3 NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine.  The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, sodium lauryl sulphate, titanium dioxide, iron oxide yellow, FD&amp;C Blue No.1. In addition 40 mg also contains FD&amp;C Yellow No.6. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>71209-042-10</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (71209-042-10) </PackageDescription>
    <NDC11Code>71209-0042-10</NDC11Code>
    <ProductNDC>71209-042</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluoxetine</ProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206993</ApplicationNumber>
    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of:  Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].  Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2 )].  Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3 )].  Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4 )]. Fluoxetine capsules and Olanzapine in Combination is indicated for the treatment of:  Acute treatment of depressive episodes associated with Bipolar I Disorder.  Treatment Resistant Depression (Major Depressive Disorder in patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
    <Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy] propylamine hydrochloride and has the empirical formula of  C17 H18 F3 NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine.  The capsules also contain the following inactive ingredients: pregelatinized starch, gelatin, sodium lauryl sulphate, titanium dioxide, iron oxide yellow, FD&amp;C Blue No.1. In addition 40 mg also contains FD&amp;C Yellow No.6. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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  <NDC>
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    <ProductNDC>71209-073</ProductNDC>
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    <StartMarketingDate>20190213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210022</ApplicationNumber>
    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin.</Description>
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    <NDCCode>71209-073-05</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (71209-073-05) </PackageDescription>
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    <ProductNDC>71209-073</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olanzapine</ProprietaryName>
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    <StartMarketingDate>20190213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210022</ApplicationNumber>
    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231004</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin.</Description>
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    <PackageDescription>500 TABLET in 1 BOTTLE (71209-073-10) </PackageDescription>
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    <StartMarketingDate>20190213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
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    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231004</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin.</Description>
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    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
    <SubstanceName>OLANZAPINE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin.</Description>
  </NDC>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
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    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin.</Description>
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    <LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
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    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
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    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin.</Description>
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    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin.</Description>
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    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin.</Description>
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    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin.</Description>
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    <IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the:  Treatment of schizophrenia. (1.1)  Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)  Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)  Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)  Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)  Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)  Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)  Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)  Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the:  Treatment of depressive episodes associated with bipolar I disorder. (1.5)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.  Treatment of treatment resistant depression. (1.6)  Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
    <Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin.</Description>
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