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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Fish and Richardson
Medtronic
Dow
Mallinckrodt
Queensland Health
US Army
McKinsey
Colorcon

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077914

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NDA 077914 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 077914
Tradename:FINASTERIDE
Applicant:Actavis Totowa Teva
Ingredient:finasteride
Patents:0
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 077914
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 077914
Suppliers and Packaging for NDA: 077914
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FINASTERIDE finasteride TABLET;ORAL 077914 ANDA Actavis Pharma, Inc. 45963-500 N 45963-500-02
FINASTERIDE finasteride TABLET;ORAL 077914 ANDA Actavis Pharma, Inc. 45963-500 N 45963-500-08

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
UBS
Argus Health
Merck
Accenture
Moodys
McKesson
Baxter
Cipla

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