Details for New Drug Application (NDA): 202133
✉ Email this page to a colleague
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 202133
Tradename: | FLUOXETINE HYDROCHLORIDE |
Applicant: | Twi Pharms |
Ingredient: | fluoxetine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202133
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 202133
Suppliers and Packaging for NDA: 202133
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 202133 | NDA | TWi Pharmaceuticals, Inc. | 24979-255 | 24979-255-06 | 30 TABLET, FILM COATED in 1 BOTTLE (24979-255-06) |
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 202133 | NDA AUTHORIZED GENERIC | Alvogen Inc. | 47781-600 | 47781-600-30 | 30 TABLET, FILM COATED in 1 BOTTLE (47781-600-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 60MG BASE | ||||
Approval Date: | Oct 6, 2011 | TE: | AB | RLD: | Yes |
Complete Access Available with Subscription