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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078572

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NDA 078572 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 078572
Tradename:FLUOXETINE HYDROCHLORIDE
Applicant:Dr Reddys Labs Ltd
Ingredient:fluoxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 078572
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 078572
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 078572 ANDA Dr.Reddy's Laboratories Limited 55111-284 55111-284-48 1 BLISTER PACK in 1 CARTON (55111-284-48) > 4 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 90MG BASE
Approval Date:Mar 22, 2010TE:ABRLD:No

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