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Details for New Drug Application (NDA): 090507

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NDA 090507 describes FINASTERIDE, which is a drug marketed by Zydus Pharms Usa Inc, Teva, Sun Pharma Global, Actavis Totowa, Accord Hlthcare, Cipla Ltd, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Aurobindo Pharma, Accord Hlthcare Inc, Gedeon Richter Usa, Hetero Labs Ltd Iii, Mylan Pharms Inc, Mylan, and Aurobindo Pharma Ltd, and is included in twenty NDAs. It is available from thirty-six 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the finasteride profile page.

Summary for NDA: 090507

Pharmacology for NDA: 090507

Mechanism of Action5-alpha Reductase Inhibitors

Suppliers and Packaging for NDA: 090507

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 090507 ANDA Sun Pharma Global FZE 47335-715 47335-715-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-715-08)
TABLET;ORAL 090507 ANDA Sun Pharma Global FZE 47335-715 47335-715-13 500 TABLET, FILM COATED in 1 BOTTLE (47335-715-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 16, 2011TE:ABRLD:No

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