Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022401
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TWYNSTA | AMLODIPINE BESYLATE; TELMISARTAN | EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
TWYNSTA | AMLODIPINE BESYLATE; TELMISARTAN | EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
TWYNSTA | AMLODIPINE BESYLATE; TELMISARTAN | EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
TWYNSTA | AMLODIPINE BESYLATE; TELMISARTAN | EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
10/16/2009 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022401lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022401s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022401_twynsta_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/22401s000sumr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/01/2018 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022401s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022401Orig1s019ltr.pdf | |
01/13/2016 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022401s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022401Orig1s018ltr.pdf | |
11/19/2015 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/12/2014 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022401s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022401Orig1s016ltr.pdf | |
12/11/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/14/2012 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s012ltr.pdf | |
03/29/2012 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401s011ltr.pdf | |
11/14/2011 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022401s010ltr.pdf | |
10/19/2012 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s007,s009ltr.pdf | |
10/19/2012 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401Orig1s007,s009ltr.pdf | |
06/06/2011 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022401s005ltr.pdf | |
01/18/2012 | SUPPL-4 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022401s004ltr.pdf | |
07/27/2010 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022401s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022401s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/01/2018 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022401s019lbl.pdf | |
01/13/2016 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022401s018lbl.pdf | |
12/12/2014 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022401s016lbl.pdf | |
11/14/2012 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s012lbl.pdf | |
10/19/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf | |
10/19/2012 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s007s009lbl.pdf | |
03/29/2012 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s011lbl.pdf | |
01/18/2012 | SUPPL-4 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022401s004lbl.pdf | |
11/14/2011 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s010lbl.pdf | |
06/06/2011 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022401s005lbl.pdf | |
07/27/2010 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022401s002lbl.pdf | |
10/16/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022401lbl.pdf |