Application 021460
- Type
- NDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METAGLIP | GLIPIZIDE; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | METAGLIP | GLIPIZIDE; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | METAGLIP | GLIPIZIDE; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 36995 | SUPPL | 2013-10-22 |
| 5448 | SUPPL | 2013-10-16 |
| 15526 | SUPPL | 2011-02-04 |
| 27853 | SUPPL | 2011-02-03 |
| 27852 | SUPPL | 2009-11-25 |
| 36994 | SUPPL | 2009-09-18 |
| 36993 | SUPPL | 2008-08-26 |
| 27851 | SUPPL | 2008-08-20 |
| 27850 | SUPPL | 2007-07-05 |
| 36992 | SUPPL | 2007-06-27 |
| 42178 | ORIG | 2003-04-30 |
| 36991 | ORIG | 2002-10-21 |
| 5447 | ORIG | 2002-10-21 |