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Serving leading biopharmaceutical companies globally:

Teva
QuintilesIMS
Healthtrust
UBS
Federal Trade Commission
Accenture
Citi
Farmers Insurance
Daiichi Sankyo
Cipla

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076165

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NDA 076165 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, Mallinckrodt, Mylan, Mylan Pharms Inc, Par Pharm, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Wockhardt Ltd, Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Hi Tech Pharma, Lannett, Pharm Assoc, Silarx, Wockhardt, Alvogen, Dr Reddys Labs Inc, Par Form, Par Pharm Inc, and Torrent Pharms Ltd, and is included in forty-seven 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-four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 076165
Tradename:FLUOXETINE HYDROCHLORIDE
Applicant:Cr Double Crane
Ingredient:fluoxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Feb 1, 2002TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Feb 1, 2002TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
UBS
Covington
Federal Trade Commission
McKinsey
QuintilesIMS
Healthtrust
Chubb

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