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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076437

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NDA 076437 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 076437

Tradename:	FINASTERIDE
Applicant:	Dr Reddys Labs Ltd
Ingredient:	finasteride
Patents:	0

Pharmacology for NDA: 076437

Mechanism of Action	5-alpha Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 076437

5-alpha Reductase Inhibitors
Urological Agents

Suppliers and Packaging for NDA: 076437

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FINASTERIDE	finasteride	TABLET;ORAL	076437	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8562	0615-8562-05	15 TABLET in 1 BLISTER PACK (0615-8562-05)
FINASTERIDE	finasteride	TABLET;ORAL	076437	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8562	0615-8562-39	30 TABLET in 1 BLISTER PACK (0615-8562-39)

Profile for product number 001

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

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