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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203687


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NDA 203687 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, Sun Pharm, Teva, and Zydus Pharms Usa Inc, and is included in twenty-two NDAs. It is available from thirty-four suppliers. Additional details are available on the FINASTERIDE profile page.

The generic ingredient in FINASTERIDE is finasteride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the finasteride profile page.
Summary for 203687
Tradename:FINASTERIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:finasteride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203687
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 203687
Suppliers and Packaging for NDA: 203687
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FINASTERIDE finasteride TABLET;ORAL 203687 ANDA Burel Pharmaceuticals, LLC 35573-400 35573-400-99 1000 TABLET, FILM COATED in 1 BOTTLE (35573-400-99)
FINASTERIDE finasteride TABLET;ORAL 203687 ANDA Rising Health, LLC 57237-061 57237-061-30 30 TABLET, FILM COATED in 1 BOTTLE (57237-061-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Nov 5, 2013TE:ABRLD:No

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