Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021269
Company: VIATRIS
Company: VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARDURA XL | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| CARDURA XL | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/22/2021 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021269Orig1s021lbl.pdf | |
| 06/22/2021 | SUPPL-21 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021269Orig1s021lbl.pdf | |
| 02/27/2017 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021269s018lbl.pdf | |
| 06/08/2015 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021269s017lbl.pdf | |
| 07/08/2011 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021269s012lbl.pdf | |
| 03/16/2010 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021269s011lbl.pdf | |
| 02/22/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021269lbl.pdf |