For type 2 diabetes mellitus. NDA 21748, held by Santarus Inc. Metformin Hydrochloride.
As of Nov 14, 2026, NDA 21748 (Glumetza), held by Santarus Inc, was first approved by FDA on Jun 3, 2005, with 9 approved supplements and 0 published complete response letters.
Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 2005 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Glumetza500MG · tablet, extended release;oral | Metformin Hydrochloride | DiscontinuedReference drug |
| Glumetza1GM · tablet, extended release;oral | Metformin Hydrochloride | DiscontinuedReference drug |
| Aug 11, 2026 | Supplement 31Labeling | Approved | |
| Nov 7, 2018 | Supplement 25Labeling · Standard review | Approved | |
| Apr 5, 2017 | Supplement 20Labeling | Approved | |
| Oct 27, 2015 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Apr 13, 2011 | Supplement 10Labeling · Standard review | Approved | |
| Feb 25, 2010 | Supplement 8Labeling · Standard review | Approved | |
| Jun 16, 2009 | Supplement 5Labeling · Standard review | Approved | |
| Dec 28, 2007 | Supplement 4Manufacturing | Approved | None posted |
| Nov 1, 2006 | Supplement 2Labeling · Standard review | Approved | |
| Jun 3, 2005 | Original applicationNew formulation or manufacturer · 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
