Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022107
Company: NODEN PHARMA
Company: NODEN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 01/18/2008 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022107s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022107_tekturna_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022107s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/28/2020 | SUPPL-34 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022107s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022107Orig1s034ltr.pdf | |
| 11/04/2016 | SUPPL-29 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022107s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022107Orig1s029ltr.pdf | |
| 12/21/2015 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/2015 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022107Orig1s026ltr.pdf | |
| 03/27/2015 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022107Orig1s025ltr.pdf | |
| 03/18/2014 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022107s024lbl.pdf | |
| 11/04/2013 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022107s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022107Orig1s023ltr.pdf | |
| 09/28/2012 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107Orig1s022ltr.pdf | |
| 04/16/2012 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s021ltr.pdf | |
| 02/02/2012 | SUPPL-19 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s019ltr.pdf |
| 01/26/2012 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s017ltr.pdf | |
| 02/14/2012 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/22107s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s016ltr.pdf | |
| 10/12/2011 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022107s014ltr.pdf | |
| 06/14/2011 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022107s013ltr.pdf | |
| 02/10/2011 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022107s009ltr.pdf | |
| 08/09/2010 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022107s007ltr.pdf | |
| 05/22/2010 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022107s005ltr.pdf | |
| 07/16/2009 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022107s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022107s002ltr.pdf | |
| 07/17/2008 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022107s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/28/2020 | SUPPL-34 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022107s034lbl.pdf | |
| 09/28/2020 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022107s034lbl.pdf | |
| 11/04/2016 | SUPPL-29 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022107s029lbl.pdf | |
| 11/04/2016 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022107s029lbl.pdf | |
| 12/22/2015 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s026lbl.pdf | |
| 03/27/2015 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s025lbl.pdf | |
| 03/18/2014 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022107s024lbl.pdf | |
| 11/04/2013 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022107s023lbl.pdf | |
| 09/28/2012 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s022lbl.pdf | |
| 04/16/2012 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s021lbl.pdf | |
| 02/14/2012 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/22107s016lbl.pdf | |
| 01/26/2012 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s017lbl.pdf | |
| 10/12/2011 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s014lbl.pdf | |
| 06/14/2011 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s011s013lbl.pdf | |
| 02/10/2011 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s009lbl.pdf | |
| 08/09/2010 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s007lbl.pdf | |
| 05/22/2010 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s005lbl.pdf | |
| 07/16/2009 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022107s002lbl.pdf | |
| 01/18/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022107lbl.pdf |