Last Updated: September 24, 2026

Details for New Drug Application (NDA): 076458

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NDA 076458 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 076458

Tradename:	FLUOXETINE HYDROCHLORIDE
Applicant:	Chartwell Molecular
Ingredient:	fluoxetine hydrochloride
Patents:	0

Pharmacology for NDA: 076458

Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 076458

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

Suppliers and Packaging for NDA: 076458

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	SOLUTION;ORAL	076458	ANDA	Chartwell RX, LLC	62135-730	62135-730-24	2 TRAY in 1 BOX (62135-730-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-730-45)
FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	SOLUTION;ORAL	076458	ANDA	Chartwell RX, LLC	62135-730	62135-730-41	120 mL in 1 BOTTLE (62135-730-41)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 20MG BASE/5ML
Approval Date:	May 14, 2004	TE:		RLD:	No

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