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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Cerilliant
Harvard Business School
Colorcon
Julphar
Covington
Farmers Insurance
Healthtrust
Cantor Fitzgerald

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202975

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NDA 202975 describes DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc and Anchen Pharms and is included in two NDAs. It is available from two suppliers. Additional details are available on the DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE profile page.

The generic ingredient in DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 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 202975
Tradename:DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Applicant:Actavis Labs Fl Inc
Ingredient:dutasteride; tamsulosin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202975
Suppliers and Packaging for NDA: 202975
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 202975 ANDA Actavis Pharma, Inc. 0591-3771 N 0591-3771-19
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 202975 ANDA Actavis Pharma, Inc. 0591-3771 N 0591-3771-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG;0.4MG
Approval Date:Nov 20, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
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QuintilesIMS
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Colorcon
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