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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 022460


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NDA 022460 describes JALYN, which is a drug marketed by Woodward and is included in one NDA. It is available from one supplier. Additional details are available on the JALYN profile page.

The generic ingredient in JALYN is dutasteride; tamsulosin hydrochloride. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.
Summary for 022460
Tradename:JALYN
Applicant:Woodward
Ingredient:dutasteride; tamsulosin hydrochloride
Patents:0
Pharmacology for NDA: 022460
Suppliers and Packaging for NDA: 022460
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JALYN dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 022460 NDA GlaxoSmithKline LLC 0173-0809 0173-0809-13 30 CAPSULE in 1 BOTTLE (0173-0809-13)
JALYN dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 022460 NDA GlaxoSmithKline LLC 0173-0809 0173-0809-59 90 CAPSULE in 1 BOTTLE (0173-0809-59)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG;0.4MG
Approval Date:Jun 14, 2010TE:ABRLD:Yes

Expired US Patents for NDA 022460

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Woodward JALYN dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 022460-001 Jun 14, 2010 ⤷  Try a Trial ⤷  Try a Trial
Woodward JALYN dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 022460-001 Jun 14, 2010 ⤷  Try a Trial ⤷  Try a Trial
Woodward JALYN dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 022460-001 Jun 14, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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