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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Colorcon
Queensland Health
Fish and Richardson
Federal Trade Commission
QuintilesIMS
UBS
US Army
Citi
Harvard Business School

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204262

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NDA 204262 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 204262
Tradename:DUTASTERIDE
Applicant:Strides Pharma
Ingredient:dutasteride
Patents:0
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 204262
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 204262
Suppliers and Packaging for NDA: 204262
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUTASTERIDE dutasteride CAPSULE;ORAL 204262 ANDA Strides Shasun Limited 64380-763 N 64380-763-05
DUTASTERIDE dutasteride CAPSULE;ORAL 204262 ANDA Strides Shasun Limited 64380-763 N 64380-763-04

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:

UBS
US Department of Justice
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Fuji
Chinese Patent Office
Teva
McKesson
Fish and Richardson
Dow

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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