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Last Updated: January 30, 2026

Details for New Drug Application (NDA): 078801


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NDA 078801 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-three 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-three suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.
Summary for 078801
Tradename:TAMSULOSIN HYDROCHLORIDE
Applicant:Synthon Bv
Ingredient:tamsulosin hydrochloride
Patents:0
Pharmacology for NDA: 078801
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 078801
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 078801 ANDA Synthon Pharmaceuticals, Inc. 63672-0021 63672-0021-9 20000 CAPSULE in 1 DRUM (63672-0021-9)
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 078801 ANDA Aphena Pharma Solutions - Tennessee, LLC 71610-910 71610-910-30 30 CAPSULE in 1 BOTTLE (71610-910-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.4MG
Approval Date:Apr 27, 2010TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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