Application 077517
- Type
- ANDA
- Sponsor
- CASI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | No | No |
| 002 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 8MG BASE | No | No |
| 003 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 24MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-1679 | Ondansetron | Ondansetron | Sandoz Inc | ANDA | Current |
| 0781-1681 | Ondansetron | Ondansetron | Sandoz Inc | ANDA | Current |
| 43353-881 | Ondansetron | Ondansetron | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 52959-991 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |