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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
Boehringer Ingelheim
Cantor Fitzgerald

Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090408

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NDA 090408 describes TAMSULOSIN HYDROCHLORIDE, which is a drug marketed by Synthon Pharms, Alkem Labs Ltd, Mylan, Anchen Pharms, Sandoz, Zydus Pharms Usa Inc, Teva Pharms, Sun Pharm Inds Ltd, Aurobindo Pharma Ltd, Wockhardt, Macleods Pharms Ltd, and Impax Labs, 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-two 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 090408

Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090408

Mechanism of ActionAdrenergic alpha-Antagonists

Suppliers and Packaging for NDA: 090408

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tamsulosin hydrochloride
CAPSULE;ORAL 090408 ANDA Mylan Pharmaceuticals Inc. 0378-2500 0378-2500-10 1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-2500-10)
tamsulosin hydrochloride
CAPSULE;ORAL 090408 ANDA Mylan Pharmaceuticals Inc. 0378-2500 0378-2500-77 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-2500-77)

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
Argus Health
Boehringer Ingelheim
Queensland Health
Johnson and Johnson
Harvard Business School

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