← FDA DRUG APPROVALS

FDA NDA · NDA022331

KAPVAY

Sponsor: CONCORDIA PHARMS INC

APPLICATION
NDA022331
TYPE
NDA
ORIGINAL APPROVAL
2009-09-29
LATEST ACTION
2020-02-06
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

KAPVAY · ReferenceDiscontinued
CLONIDINE HYDROCHLORIDE 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
JENLOGA · ReferenceDiscontinued
CLONIDINE HYDROCHLORIDE 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
KAPVAY · ReferenceDiscontinued
CLONIDINE HYDROCHLORIDE 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
JENLOGA · ReferenceDiscontinued
CLONIDINE HYDROCHLORIDE 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2020-02-06Labeling · Supplement 21 · standard — Letter ↗AP
2016-08-16Labeling · Supplement 13 · standard — Letter ↗AP
2016-07-20Manufacturing (CMC) · Supplement 16 · standardAP
2016-05-03Manufacturing (CMC) · Supplement 18 · standardAP
2015-06-05Labeling · Supplement 15 · standard — Label ↗AP
2014-11-20Efficacy · Supplement 14 · standard — Label ↗AP
2013-02-12Labeling · Supplement 12 · standard — Letter ↗AP
2010-09-28Efficacy · Supplement 2 · standard — Label ↗AP
2010-09-28Labeling · Supplement 5 · standard — Label ↗AP
2010-09-28Efficacy · Supplement 1 · standard — Review ↗AP
2009-09-29Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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