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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 208698


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NDA 208698 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Barr, Dr Reddys Labs Ltd, Accord Hlthcare, Alembic Pharms Ltd, Ani Pharms, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Cr Double Crane, Granules, Heritage, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Natco Pharma Usa, Norvium Bioscience, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Bajaj, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Upsher Smith Labs, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Endo Operations, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Rising, Slate Run Pharma, Taro, Torrent, and Twi Pharms, and is included in sixty-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-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 208698
Tradename:FLUOXETINE HYDROCHLORIDE
Applicant:Alembic
Ingredient:fluoxetine hydrochloride
Patents:0
Pharmacology for NDA: 208698
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 208698
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 208698 ANDA Alembic Pharmaceuticals Limited 46708-242 46708-242-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-242-30)
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 208698 ANDA Alembic Pharmaceuticals Limited 46708-242 46708-242-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-242-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Apr 5, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Apr 5, 2017TE:ABRLD:No

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