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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. It is available from two suppliers. Additional details are available on the KAPVAY profile page.

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

Summary for NDA: 022331

Concordia Pharms Inc
clonidine hydrochloride
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 022331

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 022331

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
clonidine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 022331 NDA Concordia Pharmaceuticals Inc. 59212-658 59212-658-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-658-60)
clonidine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 022331 NDA Concordia Pharmaceuticals Inc. 59212-659 59212-659-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-659-60)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength0.1MG
Approval Date:Sep 30, 2009TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength0.2MG
Approval Date:May 25, 2010TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.1MG
Approval Date:Sep 28, 2010TE:AB1RLD:Yes
Regulatory Exclusivity Expiration:Nov 20, 2017

Expired Orange Book Patents for NDA: 022331

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Concordia Pharms Inc
clonidine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022331-001Sep 30, 20095,869,100<subscribe>
Concordia Pharms Inc
clonidine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022331-003Sep 28, 20105,869,100<subscribe>
Concordia Pharms Inc
clonidine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022331-002May 25, 20105,869,100<subscribe>
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