Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Moodys
McKesson
Cantor Fitzgerald
Healthtrust
Federal Trade Commission
UBS
Accenture
Merck
Chubb

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090095

« Back to Dashboard

NDA 090095 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 090095
Tradename:DUTASTERIDE
Applicant:Barr
Ingredient:dutasteride
Patents:0
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 090095
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 090095
Suppliers and Packaging for NDA: 090095
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUTASTERIDE dutasteride CAPSULE;ORAL 090095 ANDA Teva Pharmaceuticals USA Inc 0093-5655 N 0093-5655-98
DUTASTERIDE dutasteride CAPSULE;ORAL 090095 ANDA Teva Pharmaceuticals USA Inc 0093-5655 N 0093-5655-56

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Dec 21, 2010TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Covington
US Department of Justice
McKinsey
Julphar
US Army
Fuji
Federal Trade Commission
Chinese Patent Office
Queensland Health

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.