Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021437
Company: UPJOHN
Company: UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INSPRA | EPLERENONE | 25MG | TABLET;ORAL | Prescription | AB | Yes | No |
| INSPRA | EPLERENONE | 50MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| INSPRA | EPLERENONE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/30/2018 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021437s015lbl.pdf | |
| 05/04/2016 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021437s013lbl.pdf | |
| 05/16/2013 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021437s011lbl.pdf | |
| 06/22/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009_2lbl.pdf | |
| 06/22/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009lbl.pdf | |
| 05/07/2008 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s006lbl.pdf | |
| 01/31/2008 | SUPPL-5 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s005lbl.pdf | |
| 10/07/2003 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21437se1-002_inspra_lbl.pdf | |
| 09/27/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21437lbl.pdf |