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Last Updated: November 24, 2024

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-five 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:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Sep 30, 2009TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 25, 2010TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength0.1MG
Approval Date:Sep 28, 2010TE:RLD:Yes

Expired US Patents for NDA 022331

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 ⤷  Sign Up ⤷  Sign Up
Concordia Pharms Inc KAPVAY clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-004 Sep 28, 2010 ⤷  Sign Up ⤷  Sign Up
Concordia Pharms Inc KAPVAY clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-003 Sep 28, 2010 ⤷  Sign Up ⤷  Sign Up
Concordia Pharms Inc JENLOGA clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022331-002 May 25, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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