NDA 21591, held by Ranbaxy. Metformin Hydrochloride.
As of Nov 14, 2026, NDA 21591 (Riomet), held by Ranbaxy, was first approved by FDA on Oct 20, 2008, with 8 approved supplements and 0 published complete response letters.
| Oct 20, 2008 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Sep 11, 2003 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Riomet500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;oral | Metformin Hydrochloride | DiscontinuedReference drug |
| Nov 6, 2018 | Supplement 7Labeling · Standard review | Approved | |
| Apr 5, 2017 | Supplement 10Labeling | Approved | |
| Aug 29, 2014 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Sep 16, 2013 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Dec 6, 2010 | Supplement 5Labeling | Approved | |
| Oct 20, 2008 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Oct 20, 2008 | Supplement 4Labeling · Standard review | Approved | |
| Sep 20, 2005 | Supplement 3Labeling · Standard review | Approved | |
| Jun 2, 2004 | Supplement 1Labeling · Standard review | Approved | |
| Sep 11, 2003 | Original applicationNew dosage form · 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
