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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Citi
Queensland Health
Farmers Insurance
US Department of Justice
Colorcon
Deloitte
Express Scripts
Julphar
Argus Health

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206373

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NDA 206373 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 206373
Tradename:DUTASTERIDE
Applicant:Intergel Pharms Inc
Ingredient:dutasteride
Patents:0
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 206373
Mechanism of Action5-alpha Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 206373
Suppliers and Packaging for NDA: 206373
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUTASTERIDE dutasteride CAPSULE;ORAL 206373 ANDA Intergel Pharmaceuticals Inc 62112-8068 N 62112-8068-2
DUTASTERIDE dutasteride CAPSULE;ORAL 206373 ANDA Intergel Pharmaceuticals Inc 62112-8068 N 62112-8068-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Mar 17, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
UBS
AstraZeneca
Harvard Business School
US Army
Queensland Health
Johnson and Johnson
Covington
Colorcon

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