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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 211444


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NDA 211444 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 Pharms, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Mylan, Mylan Pharms Inc, Natco Pharma Usa, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Akorn, Aptapharma Inc, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Par Form, Par Pharm Inc, Rising, Slate Run Pharma, Taro, Torrent, Twi Pharms, and Upsher Smith Labs, and is included in sixty-five NDAs. It is available from sixty-seven 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 211444
Tradename:FLUOXETINE HYDROCHLORIDE
Applicant:Slate Run Pharma
Ingredient:fluoxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211444
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 211444
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 211444 ANDA PEL HEALTHCARE LLC 80426-044 80426-044-01 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80426-044-01)
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 211444 ANDA PEL HEALTHCARE LLC 80426-044 80426-044-02 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80426-044-02)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Sep 13, 2022TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Sep 13, 2022TE:RLD:No

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