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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 207750

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NDA 207750 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-one 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 207750

Tradename:	FINASTERIDE
Applicant:	Alkem Labs Ltd
Ingredient:	finasteride
Patents:	0

Pharmacology for NDA: 207750

Mechanism of Action	5-alpha Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 207750

5-alpha Reductase Inhibitors
Urological Agents

Suppliers and Packaging for NDA: 207750

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FINASTERIDE	finasteride	TABLET;ORAL	207750	ANDA	A-S Medication Solutions	50090-4648	50090-4648-0	90 TABLET, COATED in 1 BOTTLE (50090-4648-0)
FINASTERIDE	finasteride	TABLET;ORAL	207750	ANDA	Ascend Laboratories, LLC	67877-455	67877-455-05	500 TABLET, COATED in 1 BOTTLE (67877-455-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jan 6, 2017	TE:	AB	RLD:	No

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