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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/23/2008 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022386lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022386s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022386_prandimet_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022386s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/05/2017 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022386Orig1s018ltr.pdf | |
12/08/2017 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022386s016lbl.pdf | |
06/04/2014 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/04/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/29/2014 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/11/2014 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/17/2013 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/17/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/24/2012 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022386s008ltr.pdf | |
03/01/2012 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022386s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022386s007ltr.pdf | |
05/28/2010 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022386s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022386s002ltr.pdf |
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 |