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Details for New Drug Application (NDA): 078015

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NDA 078015 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, and Impax Labs, and is included in ten NDAs. It is available from forty-eight 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-one suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.

Summary for NDA: 078015

tamsulosin hydrochloride
Therapeutic Class:Genitourinary Agents

Pharmacology for NDA: 078015

Mechanism of ActionAdrenergic alpha-Antagonists

Suppliers and Packaging for NDA: 078015

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tamsulosin hydrochloride
CAPSULE;ORAL 078015 ANDA Sandoz Inc 0781-2076 0781-2076-01 100 CAPSULE in 1 BOTTLE (0781-2076-01)
tamsulosin hydrochloride
CAPSULE;ORAL 078015 ANDA Sandoz Inc 0781-2076 0781-2076-10 1000 CAPSULE in 1 BOTTLE (0781-2076-10)

Summary for product number 001

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.