Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022331
Company: CONCORDIA PHARMS INC
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JENLOGA CLONIDINE HYDROCHLORIDE 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
JENLOGA CLONIDINE HYDROCHLORIDE 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
KAPVAY CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 Yes Yes
KAPVAY CLONIDINE HYDROCHLORIDE 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

JENLOGA

There are no Therapeutic Equivalents.

KAPVAY

TABLET, EXTENDED RELEASE;ORAL; 0.1MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 203320 ACTAVIS ELIZABETH
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209686 AJANTA PHARMA LTD
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 210052 AMNEAL PHARMS NY
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202984 ANCHEN PHARMS
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 210338 JUBILANT GENERICS
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209285 LUPIN LTD
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 210680 MAYNE PHARMA INC
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209675 NOVAST LABS
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209757 XIAMEN LP PHARM CO
KAPVAY CLONIDINE HYDROCHLORIDE 0.1MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 022331 CONCORDIA PHARMS INC

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