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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 078161

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NDA 078161 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, and Zydus Lifesciences, and is included in twenty-three NDAs. It is available from thirty-four 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. One supplier is listed for this compound. Additional details are available on the finasteride; tadalafil profile page.

Summary for 078161

Tradename:	FINASTERIDE
Applicant:	Natco Pharma
Ingredient:	finasteride
Patents:	0

Medical Subject Heading (MeSH) Categories for 078161

5-alpha Reductase Inhibitors
Urological Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Nov 5, 2013	TE:		RLD:	No

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