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Serving leading biopharmaceutical companies globally:

Argus Health
Express Scripts
Chinese Patent Office
Johnson and Johnson
Cantor Fitzgerald
Fish and Richardson

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204262

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NDA 204262 describes DUTASTERIDE, which is a drug marketed by West-ward Pharms Int, Breckenridge Pharm, Actavis Labs Fl Inc, Amneal Pharms, Vintage Pharms Llc, Rising Pharms Inc, Mylan Pharms Inc, Aurolife Pharma Llc, Strides Pharma, Intergel Pharms Inc, Zydus Pharms Usa Inc, Ascent Pharms Inc, Marksans Pharma, Apotex Inc, Barr, Bionpharma Inc, and Anchen Pharms, and is included in eighteen 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. Five suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.

Summary for 204262

Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 204262

Mechanism of Action5-alpha Reductase Inhibitors

Suppliers and Packaging for NDA: 204262

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 204262 ANDA Strides Shasun Limited 64380-763 64380-763-04 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (64380-763-04)
CAPSULE;ORAL 204262 ANDA Strides Shasun Limited 64380-763 64380-763-05 90 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (64380-763-05)

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Chinese Patent Office

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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