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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078938

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NDA 078938 describes TAMSULOSIN HYDROCHLORIDE, which is a drug marketed by Anchen Pharms, Aurobindo Pharma Ltd, Impax Labs, Macleods Pharms Ltd, Mylan, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Wockhardt, Zydus Pharms Usa Inc, and Alkem Labs Ltd, and is included in twelve NDAs. It is available from fifty-one 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. Fifty-two suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.
Summary for 078938
Tradename:TAMSULOSIN HYDROCHLORIDE
Applicant:Wockhardt
Ingredient:tamsulosin hydrochloride
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078938
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 078938
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 078938 ANDA Blenheim Pharmacal, Inc. 10544-550 E 10544-550-30
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 078938 ANDA Aidarex Pharmaceuticals LLC 33261-839 N 33261-839-30

Profile for product number 001

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

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