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Details for New Drug Application (NDA): 090508

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NDA 090508 describes FINASTERIDE, which is a drug marketed by Zydus Pharms Usa Inc, Alkem Labs Ltd, 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-two NDAs. It is available from thirty-eight 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-nine suppliers are listed for this compound. Additional details are available on the finasteride profile page.

Summary for NDA: 090508

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

Pharmacology for NDA: 090508

Mechanism of Action5-alpha Reductase Inhibitors

Suppliers and Packaging for NDA: 090508

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FINASTERIDE
finasteride
TABLET;ORAL 090508 ANDA A-S Medication Solutions 50090-1414 50090-1414-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-1414-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jul 1, 2013TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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