Application 021793
- Type
- NDA
- Sponsor
- MEDA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REGLAN ODT | METOCLOPRAMIDE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 5MG BASE | No | No |
| 002 | REGLAN ODT | METOCLOPRAMIDE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 10MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43781 | SUPPL | 2011-12-02 |
| 37655 | SUPPL | 2011-12-02 |
| 6196 | SUPPL | 2011-11-30 |
| 6195 | SUPPL | 2011-08-05 |
| 42314 | SUPPL | 2011-02-15 |
| 16379 | SUPPL | 2010-11-26 |
| 28609 | SUPPL | 2010-11-22 |
| 6194 | SUPPL | 2010-09-21 |
| 37654 | SUPPL | 2010-09-10 |
| 6193 | SUPPL | 2009-10-26 |
| 16378 | SUPPL | 2009-09-22 |
| 6192 | SUPPL | 2009-07-06 |
| 21819 | ORIG | 2007-07-18 |
| 37653 | ORIG | 2005-06-14 |
| 6191 | ORIG | 2005-06-14 |