NDA 22386, held by Novo Nordisk Inc. Metformin Hydrochloride; Repaglinide.
As of Nov 13, 2026, NDA 22386 (Prandimet), held by Novo Nordisk Inc, was first approved by FDA on Jun 23, 2008, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2008 | Original applicationNew combination · Standard review | Approved |
| Prandimet500MG;1MG · tablet;oral | Metformin Hydrochloride; Repaglinide | DiscontinuedReference drug |
| Prandimet500MG;2MG · tablet;oral | Metformin Hydrochloride; Repaglinide | DiscontinuedReference drug |
| Dec 8, 2017 | Supplement 16Labeling · Standard review | Approved | |
| Apr 5, 2017 | Supplement 18Labeling · Standard review | Approved | |
| Jul 29, 2014 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 11, 2014 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jun 4, 2014 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jun 4, 2014 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Oct 17, 2013 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Oct 17, 2013 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Apr 24, 2012 | Supplement 8Labeling · Standard review | Approved | |
| Mar 1, 2012 | Supplement 7Labeling · Standard review | Approved | |
| May 28, 2010 | Supplement 2Labeling | Approved | |
| Jun 23, 2008 | Original applicationNew combination · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
