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Teva
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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091643

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NDA 091643 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 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-one suppliers are listed for this compound. Additional details are available on the finasteride profile page.
Summary for 091643
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: 091643
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 091643
Suppliers and Packaging for NDA: 091643
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FINASTERIDE finasteride TABLET;ORAL 091643 ANDA Accord Healthcare, Inc. 16729-089 N 16729-089-10
FINASTERIDE finasteride TABLET;ORAL 091643 ANDA Accord Healthcare, Inc. 16729-089 N 16729-089-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Nov 5, 2013TE:ABRLD:No

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