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Last Updated: February 27, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077849

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NDA 077849 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Barr, Dr Reddys Labs Ltd, Alembic Pharms Ltd, Ani Pharms Inc, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Celltrion, Cr Double Crane, Heritage Pharms Inc, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Mylan, Mylan Pharms Inc, Par Pharm, Sandoz, Sciegen Pharms Inc, Specgx Llc, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Aurobindo Pharma Ltd, Hi Tech Pharma, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Wockhardt Bio Ag, Alvogen, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Par Form, Par Pharm Inc, Taro, Torrent, and Upsher Smith Labs, and is included in fifty-eight NDAs. It is available from sixty-three 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. Sixty-five suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 077849
Applicant:Lannett Co Inc
Ingredient:fluoxetine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 077849
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 077849
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride SOLUTION;ORAL 077849 ANDA Lannett Company, Inc. 54838-523 54838-523-40 120 mL in 1 BOTTLE, PLASTIC (54838-523-40)
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride SOLUTION;ORAL 077849 ANDA American Health Packaging 60687-244 60687-244-67 5 TRAY in 1 CASE (60687-244-67) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-244-46) > 5 mL in 1 CUP, UNIT-DOSE (60687-244-40)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 20MG BASE/5ML
Approval Date:Feb 9, 2007TE:AARLD:No

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