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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 211885

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NDA 211885 describes TAMSULOSIN HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Ascent Pharms Inc, Aurobindo Pharma Ltd, Chartwell Rx, Impax Labs, Macleods Pharms Ltd, Ph Health, Pharmobedient, Rising, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Synthon Bv, Teva Pharms, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. It is available from thirty-nine suppliers. Additional details are available on the TAMSULOSIN HYDROCHLORIDE profile page.

The generic ingredient in TAMSULOSIN HYDROCHLORIDE is tamsulosin hydrochloride. There are thirty-three drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.

Summary for 211885

Tradename:	TAMSULOSIN HYDROCHLORIDE
Applicant:	Chartwell Rx
Ingredient:	tamsulosin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.4MG
Approval Date:	Oct 17, 2019	TE:	AB	RLD:	No

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