Details for New Drug Application (NDA): 076458
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The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 076458
Tradename: | FLUOXETINE HYDROCHLORIDE |
Applicant: | Chartwell Molecular |
Ingredient: | fluoxetine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 076458
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 076458
Suppliers and Packaging for NDA: 076458
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | SOLUTION;ORAL | 076458 | ANDA | Chartwell RX, LLC | 62135-730 | 62135-730-24 | 2 TRAY in 1 BOX (62135-730-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-730-45) |
FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | SOLUTION;ORAL | 076458 | ANDA | Chartwell RX, LLC | 62135-730 | 62135-730-41 | 120 mL in 1 BOTTLE (62135-730-41) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 20MG BASE/5ML | ||||
Approval Date: | May 14, 2004 | TE: | RLD: | No |
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