Application 017498
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MICRONASE | GLYBURIDE | TABLET;ORAL | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | MICRONASE | GLYBURIDE | TABLET;ORAL | 2.5MG | No | No |
| 003 | MICRONASE | GLYBURIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|
| 33287 | SUPPL | 2015-05-27 |
| 605 | SUPPL | 2015-05-26 |
| 33286 | SUPPL | 2013-10-22 |
| 13159 | SUPPL | 2013-10-16 |
| 33285 | SUPPL | 2011-02-04 |
| 13158 | SUPPL | 2011-02-04 |
| 13157 | SUPPL | 2009-11-19 |
| 33284 | SUPPL | 2009-09-17 |
| 33283 | SUPPL | 2008-11-03 |
| 13156 | SUPPL | 2008-10-29 |