You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090508

✉ Email this page to a colleague

« Back to Dashboard

NDA 090508 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 090508

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

Pharmacology for NDA: 090508

Mechanism of Action	5-alpha Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 090508

5-alpha Reductase Inhibitors
Urological Agents

Suppliers and Packaging for NDA: 090508

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FINASTERIDE	finasteride	TABLET;ORAL	090508	ANDA	Sun Pharmaceutical Industries, Inc.	47335-714	47335-714-08	100 TABLET, FILM COATED in 1 BOTTLE (47335-714-08)
FINASTERIDE	finasteride	TABLET;ORAL	090508	ANDA	Sun Pharmaceutical Industries, Inc.	47335-714	47335-714-18	1000 TABLET, FILM COATED in 1 BOTTLE (47335-714-18)

Profile for product number 001

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.