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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Deloitte
McKesson
Covington
QuintilesIMS
Novartis
Chinese Patent Office
Chubb
Colorcon
Baxter

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204292

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NDA 204292 describes DUTASTERIDE, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Apotex Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Bionpharma Inc, Breckenridge Pharm, Haupt Pharma, Intergel Pharms Inc, Marksans Pharma, Mylan Pharms Inc, Rising Pharms Inc, Strides Pharma, Vintage Pharms Llc, West-ward Pharms Int, Zydus Pharms Usa Inc, and Anchen Pharms, and is included in nineteen NDAs. It is available from sixteen suppliers. Additional details are available on the DUTASTERIDE profile page.

The generic ingredient in DUTASTERIDE is dutasteride; tamsulosin hydrochloride. There are seventeen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.
Summary for 204292
Tradename:DUTASTERIDE
Applicant:Apotex Inc
Ingredient:dutasteride
Patents:0
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 204292
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 204292
Suppliers and Packaging for NDA: 204292
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUTASTERIDE dutasteride CAPSULE;ORAL 204292 ANDA Golden State Medical Supply, Inc. 60429-935 60429-935-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (60429-935-30)
DUTASTERIDE dutasteride CAPSULE;ORAL 204292 ANDA Golden State Medical Supply, Inc. 60429-935 60429-935-90 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (60429-935-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Nov 24, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chubb
Cipla
Johnson and Johnson
US Department of Justice
Federal Trade Commission
Julphar
Express Scripts
Boehringer Ingelheim
Teva

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