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Cerilliant
Federal Trade Commission
Express Scripts
Medtronic
Chubb
McKinsey
AstraZeneca
Covington
Deloitte

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078225

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NDA 078225 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 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-one suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.
Summary for 078225
Tradename:TAMSULOSIN HYDROCHLORIDE
Applicant:Zydus Pharms Usa Inc
Ingredient:tamsulosin hydrochloride
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078225
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 078225
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 078225 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7995 N 0615-7995-05
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 078225 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7995 N 0615-7995-39

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
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Baxter
US Army
Medtronic
Chubb
Healthtrust
Chinese Patent Office
Merck

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