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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 077914

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NDA 077914 describes FINASTERIDE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Actavis Totowa Teva, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Gedeon Richter Usa, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Mylan, Natco Pharma, Sun Pharm, Teva, Zydus Pharms Usa Inc, Novitium Pharma, and Zydus Lifesciences, and is included in twenty-four NDAs. It is available from thirty-three suppliers. Additional details are available on the FINASTERIDE profile page.

The generic ingredient in FINASTERIDE is finasteride; tadalafil. There are fourteen drug master file entries for this compound. Additional details are available on the finasteride; tadalafil profile page.

Summary for 077914

Tradename:	FINASTERIDE
Applicant:	Actavis Totowa Teva
Ingredient:	finasteride
Patents:	0

Medical Subject Heading (MeSH) Categories for 077914

5-alpha Reductase Inhibitors
Urological Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 28, 2007	TE:		RLD:	No

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