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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 211477

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NDA 211477 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, Cadila Pharms Ltd, Carlsbad, Chartwell Rx, Cr Double Crane, Heritage, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Natco Pharma Usa, Pharmobedient, Regcon Holdings, Sandoz, Sciegen Pharms, Specgx Llc, Strides Pharma Intl, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Bajaj, Chartwell Molecular, Lannett Co Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Solis Pharms, Upsher Smith Labs, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Ph Health, Rising, Somerset Theraps Llc, Strides Pharma, Torrent, and Twi Pharms, and is included in sixty-seven NDAs. It is available from sixty-three 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-four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for 211477

Tradename:	FLUOXETINE HYDROCHLORIDE
Applicant:	Somerset Theraps Llc
Ingredient:	fluoxetine hydrochloride
Patents:	0

Pharmacology for NDA: 211477

Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 211477

Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 211477

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	211477	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-5306	51672-5306-2	500 TABLET, FILM COATED in 1 BOTTLE (51672-5306-2)
FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	211477	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-5306	51672-5306-6	30 TABLET, FILM COATED in 1 BOTTLE (51672-5306-6)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 60MG BASE
Approval Date:	Nov 21, 2018	TE:	AB	RLD:	No

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