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Daiichi Sankyo
Cantor Fitzgerald
Baxter
Medtronic
Farmers Insurance
US Army
Merck
Express Scripts
Citi

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090121

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NDA 090121 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-nine 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. Forty suppliers are listed for this compound. Additional details are available on the finasteride profile page.
Summary for 090121
Tradename:FINASTERIDE
Applicant:Accord Hlthcare
Ingredient:finasteride
Patents:0
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 090121
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 090121
Suppliers and Packaging for NDA: 090121
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FINASTERIDE finasteride TABLET;ORAL 090121 ANDA Accord Healthcare, Inc. 16729-090 N 16729-090-01
FINASTERIDE finasteride TABLET;ORAL 090121 ANDA Accord Healthcare, Inc. 16729-090 N 16729-090-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 23, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Fish and Richardson
AstraZeneca
Merck
McKesson
US Army
UBS
Medtronic
Queensland Health

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