Last Updated: September 24, 2026

Details for New Drug Application (NDA): 078572

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NDA 078572 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, Marksans Pharma, Micro Labs, Natco Pharma Usa, Pharmobedient, Regcon Holdings, Sandoz, Sciegen Pharms, Senores 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, Ph Health, Rising, Somerset Theraps Llc, Strides Pharma, Torrent, and Twi Pharms, and is included in sixty-seven 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 is one drug master file entry for this compound. Sixty suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for 078572

Tradename:	FLUOXETINE HYDROCHLORIDE
Applicant:	Dr Reddys Labs Ltd
Ingredient:	fluoxetine hydrochloride
Patents:	0

Pharmacology for NDA: 078572

Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 078572

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

Suppliers and Packaging for NDA: 078572

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	078572	ANDA	Dr.Reddy's Laboratories Limited	55111-284	55111-284-48	1 BLISTER PACK in 1 CARTON (55111-284-48) / 4 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 90MG BASE
Approval Date:	Mar 22, 2010	TE:		RLD:	No

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