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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Colorcon
Moodys
Federal Trade Commission
Teva
Dow
Mallinckrodt
Healthtrust

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203118

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NDA 203118 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 seventeen 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. Four suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.
Summary for 203118
Tradename:DUTASTERIDE
Applicant:Amneal Pharms
Ingredient:dutasteride
Patents:0
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 203118
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 203118
Suppliers and Packaging for NDA: 203118
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUTASTERIDE dutasteride CAPSULE;ORAL 203118 ANDA AvKARE, Inc. 42291-257 N 42291-257-90
DUTASTERIDE dutasteride CAPSULE;ORAL 203118 ANDA Amneal Pharmaceuticals of New York, LLC 65162-750 N 65162-750-09

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Merck
Colorcon
US Department of Justice
US Army
Johnson and Johnson
Express Scripts
Dow
Moodys

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