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Details for New Drug Application (NDA): 076990

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NDA 076990 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Teva Pharms Usa, Barr, Teva, Dr Reddys Labs Inc, Mylan, Sandoz, Aurobindo Pharm, Wockhardt, Pharm Assoc, Aurobindo Pharma, Mallinckrodt, Carlsbad, Par Pharm, Alembic Pharms Ltd, Hi Tech Pharma, Edgemont Pharms Llc, Heritage Pharms Inc, Par Form, Wockhardt Ltd, Ivax Sub Teva Pharms, Silarx, Lannett, Landela Pharm, Cr Double Crane, Dr Reddys Labs Ltd, Mylan Pharms Inc, Ani Pharms Inc, Sun Pharm Inds Ltd, Actavis Mid Atlantic, Apotex Inc, and Sciegen Pharms Inc, and is included in forty-four NDAs. It is available from sixty-six suppliers. Additional details are available on the FLUOXETINE HYDROCHLORIDE profile page.

The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for NDA: 076990

Sun Pharm Inds Ltd
fluoxetine hydrochloride
Therapeutic Class:Antidepressants

Pharmacology for NDA: 076990

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 076990

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fluoxetine hydrochloride
CAPSULE;ORAL 076990 ANDA Rebel Distributors Corp 21695-054 21695-054-07 7 CAPSULE in 1 BOTTLE (21695-054-07)
fluoxetine hydrochloride
CAPSULE;ORAL 076990 ANDA Rebel Distributors Corp 21695-054 21695-054-30 30 CAPSULE in 1 BOTTLE (21695-054-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Dec 13, 2004TE:ABRLD:No

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