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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Healthtrust
Julphar
Fuji
Covington
US Department of Justice
Mallinckrodt
Chubb
Baxter

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202808

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NDA 202808 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-one NDAs. It is available from twenty-three 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. Seven suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.
Summary for 202808
Tradename:DUTASTERIDE
Applicant:Actavis Labs Fl Inc
Ingredient:dutasteride
Patents:0
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 202808
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 202808
Suppliers and Packaging for NDA: 202808
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUTASTERIDE dutasteride CAPSULE;ORAL 202808 ANDA Actavis Pharma, Inc. 0591-2292 N 0591-2292-19
DUTASTERIDE dutasteride CAPSULE;ORAL 202808 ANDA Actavis Pharma, Inc. 0591-2292 N 0591-2292-30

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:

US Army
Cipla
Teva
QuintilesIMS
Chubb
Argus Health
McKesson
Cantor Fitzgerald
Healthtrust

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