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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 207405


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NDA 207405 describes TAMSULOSIN HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Ascent Pharms Inc, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Impax Labs, Macleods Pharms Ltd, Norvium Bioscience, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Wockhardt, and Zydus Pharms Usa Inc, and is included in fourteen NDAs. It is available from forty-two 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. Forty-three suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.
Summary for 207405
Tradename:TAMSULOSIN HYDROCHLORIDE
Applicant:Alkem Labs Ltd
Ingredient:tamsulosin hydrochloride
Patents:0
Pharmacology for NDA: 207405
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 207405
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 207405 ANDA A-S Medication Solutions 50090-3646 50090-3646-0 30 CAPSULE in 1 BOTTLE (50090-3646-0)
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 207405 ANDA A-S Medication Solutions 50090-3646 50090-3646-1 90 CAPSULE in 1 BOTTLE, PLASTIC (50090-3646-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.4MG
Approval Date:Aug 11, 2017TE:ABRLD:No

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