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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Teva
Federal Trade Commission
US Army
Argus Health
Citi
AstraZeneca
QuintilesIMS
Colorcon

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076006

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NDA 076006 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Barr, Dr Reddys Labs Ltd, Alembic Pharms Ltd, Ani Pharms Inc, Aurobindo Pharma, Carlsbad, Cr Double Crane, Heritage Pharms Inc, Ivax Sub Teva Pharms, Landela Pharm, Mylan, Mylan Pharms Inc, Par Pharm, Sandoz, Sciegen Pharms Inc, Specgx Llc, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Wockhardt Ltd, Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Hi Tech Pharma, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, Alvogen, Fosun Pharma, Inventia Hlthcare, Par Form, Par Pharm Inc, and Torrent Pharms Ltd, and is included in forty-eight NDAs. It is available from seventy 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-two suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 076006
Tradename:FLUOXETINE HYDROCHLORIDE
Applicant:Dr Reddys Labs Ltd
Ingredient:fluoxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 076006
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 076006
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 076006 ANDA Dr.Reddy's Laboratories Inc. 43598-566 N 43598-566-01
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 076006 ANDA Dr.Reddy's Laboratories Inc. 43598-566 N 43598-566-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jan 30, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Apr 23, 2018TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
McKesson
Medtronic
Chubb
Queensland Health
Healthtrust
Dow
Cerilliant
Accenture

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