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TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
| 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 |