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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Cipla
Mallinckrodt
US Army
Moodys
Farmers Insurance
Express Scripts
QuintilesIMS
Cantor Fitzgerald
UBS

Generated: January 17, 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, 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 076006
Tradename:FLUOXETINE HYDROCHLORIDE
Applicant:Dr Reddys Labs Inc
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 Limited 55111-150 55111-150-78 10 BLISTER PACK in 1 CARTON (55111-150-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-150-79)
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 076006 ANDA Dr.Reddy's Laboratories Limited 55111-150 55111-150-10 1000 TABLET, FILM COATED in 1 BOTTLE (55111-150-10)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Fuji
Healthtrust
Daiichi Sankyo
McKesson
UBS
Argus Health
McKinsey
Express Scripts
Julphar

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