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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Harvard Business School
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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077251

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NDA 077251 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 forty-two 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-three suppliers are listed for this compound. Additional details are available on the finasteride profile page.

Summary for 077251

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 077251

Mechanism of Action5-alpha Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 077251

Suppliers and Packaging for NDA: 077251

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FINASTERIDE finasteride TABLET;ORAL 077251 ANDA Qualitest Pharmaceuticals 0603-3633 0603-3633-02 90 TABLET, FILM COATED in 1 BOTTLE (0603-3633-02)
FINASTERIDE finasteride TABLET;ORAL 077251 ANDA Qualitest Pharmaceuticals 0603-3633 0603-3633-21 100 TABLET, FILM COATED in 1 BOTTLE (0603-3633-21)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 22, 2006TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Julphar
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