Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 200045
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | EQ 150MG BASE;EQ 5MG BASE;12.5MG | TABLET;ORAL | Discontinued | None | No | No |
AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | EQ 300MG BASE;EQ 5MG BASE;12.5MG | TABLET;ORAL | Discontinued | None | No | No |
AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | EQ 300MG BASE;EQ 5MG BASE;25MG | TABLET;ORAL | Discontinued | None | No | No |
AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | EQ 300MG BASE;EQ 10MG BASE;12.5MG | TABLET;ORAL | Discontinued | None | No | No |
AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | EQ 300MG BASE;EQ 10MG BASE;25MG | 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 |
---|---|---|---|---|---|---|---|
12/21/2010 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200045s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200045s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200045s000_amturnide_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200045Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/04/2016 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200045s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200045Orig1s020ltr.pdf | |
12/22/2015 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200045Orig1s017ltr.pdf | |
03/27/2015 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200045Orig1s016ltr.pdf | |
03/18/2014 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200045s015lbl.pdf | |
11/04/2013 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200045s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200045Orig1s014ltr.pdf | |
09/28/2012 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s011,s013ltr.pdf | |
04/18/2012 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s012ltr_rev1rev2nh_Redacted.pdf | |
09/28/2012 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s011,s013ltr.pdf | |
02/02/2012 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s010ltr.pdf | |
11/02/2011 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s009ltr.pdf | |
01/26/2012 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s007ltr.pdf | |
02/14/2012 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s006ltr.pdf | |
10/12/2011 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s003,s004ltr.pdf | |
10/12/2011 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s003,s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/04/2016 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200045s020lbl.pdf | |
12/22/2015 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s017lbl.pdf | |
03/27/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s016lbl.pdf | |
03/18/2014 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200045s015lbl.pdf | |
11/04/2013 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200045s014lbl.pdf | |
09/28/2012 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s011s013lbl.pdf | |
09/28/2012 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s011s013lbl.pdf | |
04/18/2012 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s012lbl.pdf | |
02/14/2012 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s006lbl.pdf | |
02/02/2012 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s010lbl.pdf | |
01/26/2012 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s007lbl.pdf | |
11/02/2011 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s009lbl.pdf | |
10/12/2011 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf | |
10/12/2011 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf | |
12/21/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200045s000lbl.pdf |