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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 090060

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NDA 090060 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 090060

Tradename:	FINASTERIDE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	finasteride
Patents:	0

Pharmacology for NDA: 090060

Mechanism of Action	5-alpha Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 090060

5-alpha Reductase Inhibitors
Urological Agents

Suppliers and Packaging for NDA: 090060

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FINASTERIDE	finasteride	TABLET;ORAL	090060	ANDA	Camber Pharmaceuticals, Inc.	31722-526	31722-526-10	1000 TABLET, FILM COATED in 1 BOTTLE (31722-526-10)
FINASTERIDE	finasteride	TABLET;ORAL	090060	ANDA	Camber Pharmaceuticals, Inc.	31722-526	31722-526-30	30 TABLET, FILM COATED in 1 BOTTLE (31722-526-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jul 1, 2013	TE:	AB	RLD:	No

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