Details for New Drug Application (NDA): 076990
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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 076990
Tradename: | FLUOXETINE HYDROCHLORIDE |
Applicant: | Sun Pharm Inds Ltd |
Ingredient: | fluoxetine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076990
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 076990
Suppliers and Packaging for NDA: 076990
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | CAPSULE;ORAL | 076990 | ANDA | Proficient Rx LP | 63187-089 | 63187-089-30 | 30 CAPSULE in 1 BOTTLE (63187-089-30) |
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | CAPSULE;ORAL | 076990 | ANDA | Proficient Rx LP | 63187-089 | 63187-089-90 | 90 CAPSULE in 1 BOTTLE (63187-089-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Dec 13, 2004 | TE: | RLD: | No |
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