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Last Updated: August 14, 2020

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Details for New Drug Application (NDA): 203836

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NDA 203836 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, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Par Form, Par Pharm Inc, Taro, Torrent, and Upsher Smith Labs, and is included in sixty NDAs. It is available from fifty-nine 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-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 203836
Tradename:FLUOXETINE HYDROCHLORIDE
Applicant:Par Form
Ingredient:fluoxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203836
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 203836
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 203836 ANDA Par Pharmaceutical, Inc. 49884-335 49884-335-01 100 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-01)
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 203836 ANDA Par Pharmaceutical, Inc. 49884-335 49884-335-10 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Aug 19, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Aug 19, 2016TE:ABRLD:No

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