Details for New Drug Application (NDA): 022460

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NDA 022460 describes JALYN, which is a drug marketed by Waylis Therap 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. Six suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.

Summary for 022460

Tradename:	JALYN
Applicant:	Waylis Therap
Ingredient:	dutasteride; tamsulosin hydrochloride
Patents:	0

Pharmacology for NDA: 022460

Mechanism of Action	5-alpha Reductase Inhibitors Adrenergic alpha-Antagonists

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	Waylis Therapeutics	80725-809	80725-809-13	30 CAPSULE in 1 BOTTLE, PLASTIC (80725-809-13)
JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460	NDA	Waylis Therapeutics	80725-809	80725-809-59	90 CAPSULE in 1 BOTTLE, PLASTIC (80725-809-59)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MG;0.4MG
Approval Date:	Jun 14, 2010	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022460

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010	⤷ Sign Up	⤷ Sign Up
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010	⤷ Sign Up	⤷ Sign Up
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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