Details for New Drug Application (NDA): 075872
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The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 075872
Tradename: | FLUOXETINE HYDROCHLORIDE |
Applicant: | Teva |
Ingredient: | fluoxetine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075872
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 075872
Suppliers and Packaging for NDA: 075872
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 075872 | ANDA | Proficient Rx LP | 63187-218 | 63187-218-30 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-218-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jan 29, 2002 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Jan 4, 2019 | TE: | RLD: | No |
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