Last Updated: November 8, 2026

Details for New Drug Application (NDA): 216953

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NDA 216953 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 216953

Tradename:	FLUOXETINE HYDROCHLORIDE
Applicant:	Upsher Smith Labs
Ingredient:	fluoxetine hydrochloride
Patents:	0

Pharmacology for NDA: 216953

Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 216953

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

Suppliers and Packaging for NDA: 216953

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	SOLUTION;ORAL	216953	ANDA	Upsher-Smith Laboratories, LLC	0832-6032	0832-6032-12	1 BOTTLE in 1 CARTON (0832-6032-12) / 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 20MG BASE/5ML
Approval Date:	Nov 15, 2022	TE:	AA	RLD:	No

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