NDA 20741, held by Gemini Labs LLC. Repaglinide.
As of Nov 14, 2026, NDA 20741 (Prandin), held by Gemini Labs LLC, was first approved by FDA on Dec 22, 1997, with 27 approved supplements and 0 published complete response letters.
| Oct 21, 2002 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2002 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Dec 22, 1997 | Original applicationNew molecular entity · Priority review | Approved |
| Prandin0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Repaglinide | DiscontinuedReference drug |
| Prandin1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Repaglinide | DiscontinuedReference drug |
| Prandin2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Repaglinide | DiscontinuedReference drug |
| Jan 22, 2019 | Supplement 44Labeling · Standard review | Approved | |
| Feb 8, 2017 | Supplement 42Labeling · Standard review | Approved | |
| Feb 8, 2017 | Supplement 41Labeling | Approved | |
| Oct 30, 2015 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Mar 1, 2012 | Supplement 40Labeling · Standard review | Approved | |
| Jul 29, 2010 | Supplement 38Labeling | Approved | |
| Jun 10, 2009 | Supplement 35Labeling · Standard review | Approved | |
| Jul 14, 2008 | Supplement 34Labeling · Standard review | Approved | |
| Jun 19, 2006 | Supplement 30Labeling · Standard review | Approved | |
| Feb 10, 2005 | Supplement 22Labeling · Standard review | Approved | |
| Oct 15, 2003 | Supplement 19Manufacturing · Priority review | Approved | |
| Aug 27, 2003 | Supplement 18Labeling · Standard review | Approved | |
| Nov 25, 2002 | Supplement 16Manufacturing · Priority review | Approved | |
| Oct 21, 2002 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Oct 1, 2002 | Supplement 15Manufacturing · Priority review | Approved | |
| Aug 5, 2002 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jan 18, 2002 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Oct 27, 2000 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Aug 15, 2000 | Supplement 9Manufacturing · Priority review | Approved | |
| Feb 25, 2000 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Dec 8, 1999 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Nov 26, 1999 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Aug 30, 1999 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Aug 10, 1999 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 18, 1999 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| May 18, 1999 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Mar 1, 1999 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Dec 22, 1997 | Original applicationNew molecular entity · Priority 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
