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Last Updated: March 28, 2024

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, 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 076437
Tradename:FINASTERIDE
Applicant:Dr Reddys Labs Ltd
Ingredient:finasteride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076437
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 076437
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 Dr. Reddy's Laboratories Limited 55111-172 55111-172-01 100 TABLET in 1 BOTTLE (55111-172-01)
FINASTERIDE finasteride TABLET;ORAL 076437 ANDA Dr. Reddy's Laboratories Limited 55111-172 55111-172-05 500 TABLET in 1 BOTTLE (55111-172-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 28, 2007TE:ABRLD:No

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