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Last Updated: November 8, 2024

Details for New Drug Application (NDA): 075245

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NDA 075245 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, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Cr Double Crane, Granules, Heritage, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Natco Pharma Usa, Norvium Bioscience, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Bajaj, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Upsher Smith Labs, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Endo Operations, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Rising, Slate Run Pharma, Taro, Torrent, and Twi Pharms, and is included in sixty-seven NDAs. It is available from sixty-nine 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. Seventy suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Summary for 075245

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

Medical Subject Heading (MeSH) Categories for 075245

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jan 31, 2002	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jan 31, 2002	TE:	AB1	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Sep 28, 2004	TE:	AB	RLD:	No

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