BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Johnson and Johnson
Colorcon
Daiichi Sankyo
Fuji
Chinese Patent Office
Dow
Deloitte
Julphar

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077469

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NDA 077469 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 077469
Tradename:FLUOXETINE HYDROCHLORIDE
Applicant:Sandoz
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:Nov 17, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Nov 17, 2008TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Moodys
QuintilesIMS
Deloitte
Accenture
Cantor Fitzgerald
McKesson
Harvard Business School
Boehringer Ingelheim
Merck

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