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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Baxter
Merck
Daiichi Sankyo
Mallinckrodt
Fuji
US Department of Justice
Harvard Business School
Federal Trade Commission

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075658

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NDA 075658 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, Pharm Assoc, Silarx, Wockhardt Bio Ag, Alvogen, Dr Reddys Labs Inc, 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 075658
Tradename:FLUOXETINE HYDROCHLORIDE
Applicant:Specgx Llc
Ingredient:fluoxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 075658
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 075658
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075658 ANDA Physicians Total Care, Inc. 54868-5663 E 54868-5663-0
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075658 ANDA Physicians Total Care, Inc. 54868-5663 E 54868-5663-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Jan 29, 2002TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Jan 29, 2002TE:AB1RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
QuintilesIMS
Teva
Daiichi Sankyo
Harvard Business School
UBS
Mallinckrodt
Accenture
McKinsey

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