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Harvard Business School
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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090377

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NDA 090377 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-three suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.
Summary for 090377
Applicant:Impax Labs
Ingredient:tamsulosin hydrochloride
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090377
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 090377
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 090377 ANDA Physicians Total Care, Inc. 54868-4437 E 54868-4437-2
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 090377 ANDA Physicians Total Care, Inc. 54868-4437 E 54868-4437-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.4MG
Approval Date:Mar 2, 2010TE:ABRLD:No

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