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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022331
Company: CONCORDIA PHARMS INC

Products on NDA 022331

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JENLOGA	CLONIDINE HYDROCHLORIDE	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
JENLOGA	CLONIDINE HYDROCHLORIDE	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
KAPVAY	CLONIDINE HYDROCHLORIDE	0.1MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
KAPVAY	CLONIDINE HYDROCHLORIDE	0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022331

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2009	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022331lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022331s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022331_jenloga_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2020	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022331s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022331Orig1s021ltr.pdf
05/03/2016	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
07/20/2016	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/05/2015	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022331s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022331Orig1s015ltr.pdf
11/20/2014	SUPPL-14	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022331s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022331Orig1s014ltr.pdf
08/16/2016	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022331s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022331Orig1s013ltr.pdf
02/12/2013	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022331s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022331Orig1s012ltr.pdf
09/28/2010	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022331s005ltr.pdf
09/28/2010	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s001s002lbl.pdf
09/28/2010	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022331s001,s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022331Orig1s001.pdf

Labels for NDA 022331

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2020	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022331s021lbl.pdf
08/16/2016	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022331s013lbl.pdf
06/05/2015	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022331s015lbl.pdf
11/20/2014	SUPPL-14	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022331s014lbl.pdf
02/12/2013	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022331s012lbl.pdf
09/28/2010	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s005lbl.pdf
09/28/2010	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s001s002lbl.pdf
09/28/2010	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022331s001s002lbl.pdf
09/29/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022331lbl.pdf

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