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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 204645

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NDA 204645 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 204645

Tradename:	TAMSULOSIN HYDROCHLORIDE
Applicant:	Macleods Pharms Ltd
Ingredient:	tamsulosin hydrochloride
Patents:	0

Pharmacology for NDA: 204645

Mechanism of Action	Adrenergic alpha-Antagonists

Suppliers and Packaging for NDA: 204645

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	204645	ANDA	Macleods Pharmaceuticals Limited	33342-159	33342-159-07	30 CAPSULE in 1 BOTTLE (33342-159-07)
TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	204645	ANDA	Macleods Pharmaceuticals Limited	33342-159	33342-159-11	100 CAPSULE in 1 BOTTLE (33342-159-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.4MG
Approval Date:	Jan 20, 2017	TE:	AB	RLD:	No

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