Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021268
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TEVETEN HCT | EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE | 600MG;12.5MG | TABLET;ORAL | Discontinued | None | No | No |
| TEVETEN HCT | EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE | 600MG;25MG | TABLET;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/22/2014 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021268s019lbl.pdf | |
| 09/12/2012 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s018lbl.pdf | |
| 01/19/2012 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s017lbl.pdf | |
| 05/19/2011 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf | |
| 05/19/2011 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf | |
| 11/01/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_TEVETEN_prntlbl.pdf |