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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 076001

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NDA 076001 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 076001

Tradename:	FLUOXETINE HYDROCHLORIDE
Applicant:	Teva Pharms Usa
Ingredient:	fluoxetine hydrochloride
Patents:	0

Pharmacology for NDA: 076001

Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 076001

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

Suppliers and Packaging for NDA: 076001

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	076001	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7625	0615-7625-05	15 CAPSULE in 1 BLISTER PACK (0615-7625-05)
FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	076001	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7625	0615-7625-39	30 CAPSULE in 1 BLISTER PACK (0615-7625-39)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jan 29, 2002	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jan 29, 2002	TE:	AB1	RLD:	No

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