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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 022331

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NDA 022331 describes KAPVAY, which is a drug marketed by Concordia Pharms Inc and is included in one NDA. Additional details are available on the KAPVAY profile page.

The generic ingredient in KAPVAY is clonidine hydrochloride. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.

Summary for 022331

Tradename:	KAPVAY
Applicant:	Concordia Pharms Inc
Ingredient:	clonidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 30, 2009	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 25, 2010	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	0.1MG
Approval Date:	Sep 28, 2010	TE:		RLD:	Yes

Expired US Patents for NDA 022331

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Concordia Pharms Inc	JENLOGA	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-001	Sep 30, 2009	5,869,100	⤷ Get Started Free
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-004	Sep 28, 2010	5,869,100	⤷ Get Started Free
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-003	Sep 28, 2010	5,869,100	⤷ Get Started Free
Concordia Pharms Inc	JENLOGA	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-002	May 25, 2010	5,869,100	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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