Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022545
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TEKAMLO | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE | EQ 150MG BASE;EQ 5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| TEKAMLO | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE | EQ 150MG BASE;EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| TEKAMLO | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE | EQ 300MG BASE;EQ 5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| TEKAMLO | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE | EQ 300MG BASE;EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 08/26/2010 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022545s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022545s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022545_tekamlo_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022545Origs000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/04/2016 | SUPPL-20 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022545s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022545Orig1s020ltr.pdf | |
| 12/22/2015 | SUPPL-17 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022545Orig1s017ltr.pdf | |
| 03/27/2015 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022545Orig1s016ltr.pdf | |
| 03/18/2014 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022545s015lbl.pdf | |
| 11/04/2013 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022545s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022545Orig1s014ltr.pdf | |
| 09/28/2012 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545Orig1s011,s013ltr.pdf | |
| 04/16/2012 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s012ltr.pdf | |
| 09/28/2012 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545Orig1s011,s013ltr.pdf | |
| 02/02/2012 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s010ltr.pdf | |
| 11/14/2011 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s008ltr.pdf | |
| 01/26/2012 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s007lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s007ltr.pdf | |
| 10/12/2011 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s005ltr.pdf | |
| 03/30/2011 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/04/2016 | SUPPL-20 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022545s020lbl.pdf | |
| 11/04/2016 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022545s020lbl.pdf | |
| 12/22/2015 | SUPPL-17 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s017lbl.pdf | |
| 12/22/2015 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s017lbl.pdf | |
| 03/27/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s016lbl.pdf | |
| 03/18/2014 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022545s015lbl.pdf | |
| 11/04/2013 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022545s014lbl.pdf | |
| 09/28/2012 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf | |
| 09/28/2012 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf | |
| 04/16/2012 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s012lbl.pdf | |
| 02/02/2012 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s010lbl.pdf | |
| 01/26/2012 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s007lbledt.pdf | |
| 11/14/2011 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s008lbl.pdf | |
| 10/12/2011 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s005lbl.pdf | |
| 03/30/2011 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s001lbl.pdf | |
| 08/26/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022545s000lbl.pdf |