Application 021097
- Type
- NDA
- Sponsor
- SALIX PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VISICOL | SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | TABLET;ORAL | 0.398GM;1.102GM | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 70055 | SUPPL | 2022-02-02 |
| 43707 | ORIG | 2013-03-19 |
| 36111 | SUPPL | 2013-03-08 |
| 4326 | SUPPL | 2013-03-08 |
| 26763 | SUPPL | 2011-12-14 |
| 21447 | SUPPL | 2011-10-10 |
| 26762 | SUPPL | 2009-11-25 |
| 36110 | SUPPL | 2009-10-14 |
| 4325 | SUPPL | 2009-03-27 |
| 36109 | SUPPL | 2009-03-26 |
| 44097 | ORIG | 2006-10-11 |
| 36108 | SUPPL | 2006-05-02 |
| 26761 | SUPPL | 2006-04-07 |
| 26760 | SUPPL | 2005-02-11 |
| 4324 | SUPPL | 2005-02-11 |
| 26759 | SUPPL | 2002-03-12 |
| 41951 | ORIG | 2000-09-21 |
| 14382 | ORIG | 2000-09-21 |
| 4323 | ORIG | 2000-09-21 |