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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076511

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NDA 076511 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-one 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-two suppliers are listed for this compound. Additional details are available on the finasteride profile page.

Summary for 076511

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: 076511

Mechanism of Action5-alpha Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 076511

Suppliers and Packaging for NDA: 076511

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FINASTERIDE finasteride TABLET;ORAL 076511 ANDA Teva Pharmaceuticals USA, Inc. 0093-7355 0093-7355-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7355-56)
FINASTERIDE finasteride TABLET;ORAL 076511 ANDA Teva Pharmaceuticals USA, Inc. 0093-7355 0093-7355-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-7355-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 15, 2006TE:ABRLD:No


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McKesson

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