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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090507

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NDA 090507 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 090507

Tradename:	FINASTERIDE
Applicant:	Sun Pharm
Ingredient:	finasteride
Patents:	0

Pharmacology for NDA: 090507

Mechanism of Action	5-alpha Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 090507

5-alpha Reductase Inhibitors
Urological Agents

Suppliers and Packaging for NDA: 090507

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FINASTERIDE	finasteride	TABLET;ORAL	090507	ANDA	Sun Pharmaceutical Industries, Inc.	47335-715	47335-715-08	100 TABLET, FILM COATED in 1 BOTTLE (47335-715-08)
FINASTERIDE	finasteride	TABLET;ORAL	090507	ANDA	Sun Pharmaceutical Industries, Inc.	47335-715	47335-715-13	500 TABLET, FILM COATED in 1 BOTTLE (47335-715-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Aug 16, 2011	TE:	AB	RLD:	No

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