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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 216448

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NDA 216448 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 Inc, 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, Appco, Aurobindo Pharma Ltd, Dr Reddys, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Ph Health, Rising, Strides Pharma, Torrent, and Twi Pharms, and is included in sixty-seven NDAs. It is available from sixty-six 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-seven suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for 216448

Tradename:	FLUOXETINE HYDROCHLORIDE
Applicant:	Novitium Pharma
Ingredient:	fluoxetine hydrochloride
Patents:	0

Pharmacology for NDA: 216448

Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 216448

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

Suppliers and Packaging for NDA: 216448

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	SOLUTION;ORAL	216448	ANDA	REMEDYREPACK INC.	70518-3838	70518-3838-0	10 CUP in 1 BOX (70518-3838-0) / 5 mL in 1 CUP (70518-3838-1)
FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	SOLUTION;ORAL	216448	ANDA	ANI Pharmaceuticals, Inc.	70954-600	70954-600-10	120 mL in 1 BOTTLE, PLASTIC (70954-600-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 20MG BASE/5ML
Approval Date:	Nov 9, 2022	TE:	AA	RLD:	No

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