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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Cantor Fitzgerald
Federal Trade Commission

Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202660

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NDA 202660 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, Humanwell Puracap, 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 twenty NDAs. It is available from eighteen 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 202660
Applicant:Aurolife Pharma Llc
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202660

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Nov 20, 2015TE:ABRLD:No

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US Department of Justice
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Argus Health
Harvard Business School

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