Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020591
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TARKA | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
TARKA | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
TARKA | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
TARKA | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 2MG;240MG | 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 |
---|---|---|---|---|---|---|---|
10/22/1996 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/20/2019 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020591s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020591Orig1s030ltr.pdf | |
08/02/2017 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020591s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020591Orig1s029ltr.pdf | |
07/12/2016 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020591Orig1s027ltr.pdf | |
01/29/2016 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020591Orig1s026ltr.pdf | |
12/24/2014 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020591s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020591Orig1s025ltr.pdf | |
01/05/2015 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/20/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/12/2012 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020591s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020591Orig1s021ltr.pdf | |
01/23/2012 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020528s020,020591s020ltr.pdf | |
11/14/2011 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s019ltr.pdf | |
09/14/2011 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s018ltr.pdf | |
03/05/2009 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020591s016ltr.pdf |
08/29/2011 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020591s012ltr.pdf | |
02/29/2008 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020591s011ltr.pdf |
08/20/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/31/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/14/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/01/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/03/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/22/1997 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/20/2019 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020591s030lbl.pdf | |
08/02/2017 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020591s029lbl.pdf | |
07/12/2016 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591s027lbl.pdf | |
01/29/2016 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020591s026lbl.pdf | |
12/24/2014 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020591s025lbl.pdf | |
09/12/2012 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020591s021lbl.pdf | |
01/23/2012 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf | |
11/14/2011 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s019lbl.pdf | |
09/14/2011 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s018lbl.pdf | |
08/29/2011 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s012lbl.pdf |