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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Argus Health
Colorcon
Express Scripts
Merck
Julphar
Cerilliant
Covington

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090060

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NDA 090060 describes FINASTERIDE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Actavis Totowa Teva, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla Ltd, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Gedeon Richter Usa, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Sun Pharma Global, Teva, and Zydus Pharms Usa Inc, and is included in twenty-two NDAs. It is available from thirty-five 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-six suppliers are listed for this compound. Additional details are available on the finasteride profile page.
Summary for 090060
Tradename:FINASTERIDE
Applicant:Hetero Labs Ltd Iii
Ingredient:finasteride
Patents:0
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 090060
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 090060
Suppliers and Packaging for NDA: 090060
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FINASTERIDE finasteride TABLET;ORAL 090060 ANDA Camber Pharmaceuticals, Inc. 31722-526 N 31722-526-90
FINASTERIDE finasteride TABLET;ORAL 090060 ANDA Camber Pharmaceuticals, Inc. 31722-526 N 31722-526-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jul 1, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
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Johnson and Johnson
Moodys
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