Application 022246
- Type
- NDA
- Sponsor
- SALIX PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METOZOLV ODT | METOCLOPRAMIDE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 5MG BASE | Yes | No |
| 002 | METOZOLV ODT | METOCLOPRAMIDE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57913 | SUPPL | 2019-03-06 |
| 57912 | SUPPL | 2019-03-06 |
| 57859 | SUPPL | 2019-03-01 |
| 38416 | SUPPL | 2011-09-30 |
| 7081 | SUPPL | 2011-09-29 |
| 7080 | SUPPL | 2011-09-06 |
| 29436 | SUPPL | 2010-11-22 |
| 38415 | SUPPL | 2010-11-18 |
| 44713 | ORIG | 2010-03-30 |
| 42460 | ORIG | 2010-03-30 |
| 23369 | ORIG | 2009-10-19 |
| 17112 | ORIG | 2009-09-18 |
| 7079 | ORIG | 2009-09-09 |