Last Updated: November 8, 2026

Details for New Drug Application (NDA): 213265

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NDA 213265 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Barr, Dr Reddys Labs Ltd, Accord Hlthcare, Alembic Pharms Ltd, Ani Pharms, Aurobindo Pharma, Cadila Pharms Ltd, Carlsbad, Chartwell Rx, Cr Double Crane, Heritage, Ivax Sub Teva Pharms, Landela Pharm, Micro Labs, Natco Pharma Usa, Pharmazone, 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, Adaptis, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Fosun Pharma, G And W Labs Inc, Lupin, Ph Health, Rising, Somerset Theraps Llc, Strides Pharma, Torrent, and Twi Pharms, and is included in sixty-seven NDAs. It is available from fifty-eight suppliers. Additional details are available on the FLUOXETINE HYDROCHLORIDE profile page.

The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There is one drug master file entry for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for 213265

Tradename:	FLUOXETINE HYDROCHLORIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	fluoxetine hydrochloride
Patents:	0

Pharmacology for NDA: 213265

Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 213265

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

Suppliers and Packaging for NDA: 213265

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	213265	ANDA	Aurobindo Pharma Limited	59651-324	59651-324-30	30 TABLET, FILM COATED in 1 BOTTLE (59651-324-30)
FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	213265	ANDA	Bryant Ranch Prepack	71335-2597	71335-2597-1	30 TABLET, FILM COATED in 1 BOTTLE (71335-2597-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 60MG BASE
Approval Date:	Jun 10, 2020	TE:	AB	RLD:	No

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