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Last Updated: November 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209695

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NDA 209695 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Barr, Dr Reddys Labs Ltd, Alembic Pharms Ltd, Ani Pharms Inc, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Celltrion, Cr Double Crane, Heritage Pharms Inc, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Mylan, Mylan Pharms Inc, Par Pharm, Sandoz, Sciegen Pharms Inc, Specgx Llc, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Aurobindo Pharma Ltd, Hi Tech Pharma, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Wockhardt Bio Ag, Alvogen, Appco Pharma Llc, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Par Form, Par Pharm Inc, Torrent, and Upsher Smith Labs, and is included in fifty-eight NDAs. It is available from sixty-six 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. Sixty-eight suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 209695
Tradename:FLUOXETINE HYDROCHLORIDE
Applicant:Inventia Hlthcare
Ingredient:fluoxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209695
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 209695
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 209695 ANDA Nivagen Pharmaceuticals, Inc. 75834-148 75834-148-30 30 TABLET in 1 BOTTLE (75834-148-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:Nov 20, 2017TE:ABRLD:No

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