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Last Updated: December 12, 2025

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, Aurobindo Pharma, Ph Health, and Zydus Pharms, and is included in four NDAs. It is available from five 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 eighteen 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 202975

Tradename:	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Applicant:	Actavis Labs Fl Inc
Ingredient:	dutasteride; tamsulosin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.5MG;0.4MG
Approval Date:	Nov 20, 2015	TE:		RLD:	No

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