NDA 21460, held by Bristol Myers Squibb. Glipizide; Metformin Hydrochloride.
As of Nov 14, 2026, NDA 21460 (Metaglip), held by Bristol Myers Squibb, was first approved by FDA on Oct 21, 2002, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2002 | Original applicationNew combination · Standard review | Approved |
| Metaglip2.5MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Glipizide; Metformin Hydrochloride | DiscontinuedReference drug |
| Metaglip2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Glipizide; Metformin Hydrochloride | DiscontinuedReference drug |
| Metaglip5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Glipizide; Metformin Hydrochloride | DiscontinuedReference drug |
| Oct 15, 2013 | Supplement 10Labeling · Standard review | Approved | |
| Feb 1, 2011 | Supplement 9Labeling · Standard review | Approved | |
| Aug 7, 2009 | Supplement 8Labeling · Standard review | Approved | |
| Aug 18, 2008 | Supplement 7Labeling · Standard review | Approved | |
| Jun 18, 2007 | Supplement 5Labeling · Standard review | Approved | |
| Oct 21, 2002 | 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
