Application 022524
- Type
- NDA
- Sponsor
- MIDATECH PHARMA US
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZUPLENZ | ONDANSETRON | FILM;ORAL | 4MG | Yes | No |
| 002 | ZUPLENZ | ONDANSETRON | FILM;ORAL | 8MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 89141-444 | ZUPLENZ | ondansetron | Midatech Pharma US, Inc. | NDA | Current |
| 89141-444 | ZUPLENZ | ondansetron | Midatech Pharma US, Inc. | NDA | Current |
| 89141-444 | ZUPLENZ | ondansetron | Fortovia Therapeutics, Inc. | NDA | Current |
| 89141-444 | ZUPLENZ | ondansetron | Fortovia Therapeutics, Inc. | NDA | Current |
| 89141-448 | ZUPLENZ | ondansetron | Midatech Pharma US, Inc. | NDA | Current |
| 89141-448 | ZUPLENZ | ondansetron | Midatech Pharma US, Inc. | NDA | Current |
| 89141-448 | ZUPLENZ | ondansetron | Fortovia Therapeutics, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68321 | SUPPL | 2021-08-09 |
| 68302 | SUPPL | 2021-08-06 |
| 7498 | SUPPL | 2014-09-23 |
| 38810 | SUPPL | 2014-09-22 |
| 29828 | SUPPL | 2013-10-31 |
| 17679 | SUPPL | 2013-10-31 |
| 44770 | ORIG | 2011-05-13 |
| 42550 | ORIG | 2011-05-13 |
| 29827 | ORIG | 2010-07-27 |
| 38809 | ORIG | 2010-07-12 |