Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022386
Company: NOVO NORDISK INC
Company: NOVO NORDISK INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRANDIMET | METFORMIN HYDROCHLORIDE; REPAGLINIDE | 500MG;1MG | TABLET;ORAL | Discontinued | None | Yes | No |
| PRANDIMET | METFORMIN HYDROCHLORIDE; REPAGLINIDE | 500MG;2MG | TABLET;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/08/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s016lbl.pdf | |
| 04/05/2017 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s018lbl.pdf | |
| 04/24/2012 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s000lbl.pdf | |
| 03/01/2012 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s007lbl.pdf | |
| 05/28/2010 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022386s002lbl.pdf | |
| 06/23/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022386lbl.pdf |