Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022331
Company: CONCORDIA PHARMS INC
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JENLOGA | CLONIDINE HYDROCHLORIDE | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
JENLOGA | CLONIDINE HYDROCHLORIDE | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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KAPVAY | CLONIDINE HYDROCHLORIDE | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
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 |
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 |