Application 022456
- Type
- NDA
- Sponsor
- SANTARUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE | MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE | TABLET;ORAL | 343MG;20MG;750MG | No | No |
| 002 | MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE | MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE | TABLET;ORAL | 343MG;40MG;750MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 38725 | SUPPL | 2012-12-13 |
| 29743 | SUPPL | 2012-12-13 |
| 17598 | SUPPL | 2012-05-29 |
| 29744 | SUPPL | 2012-05-24 |
| 38724 | SUPPL | 2011-12-14 |
| 7407 | SUPPL | 2011-12-13 |
| 29742 | SUPPL | 2011-05-25 |
| 17597 | SUPPL | 2010-09-10 |
| 29741 | SUPPL | 2010-09-08 |
| 42531 | ORIG | 2010-03-25 |
| 24313 | ORIG | 2010-03-25 |
| 38723 | ORIG | 2010-01-07 |
| 29740 | ORIG | 2010-01-07 |