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Serving 500+ biopharmaceutical companies globally:

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Generated: August 20, 2017

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 Synthon Pharms, 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 eleven 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-two 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 NDA: 078938

Tradename:
1
Applicant:
1
Ingredient:
1
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 10544-550-30 30 CAPSULE in 1 BOTTLE (10544-550-30)
TAMSULOSIN HYDROCHLORIDE
tamsulosin hydrochloride
CAPSULE;ORAL 078938 ANDA STAT RX USA LLC 16590-298 16590-298-30 30 CAPSULE in 1 BOTTLE (16590-298-30)

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 500+ biopharmaceutical companies globally:

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