Application 076930
- Type
- ANDA
- Sponsor
- MYLAN
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 16MG | No | No |
| 004 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 24MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0315 | Ondansetron | ondansetron | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-0315 | Ondansetron | ondansetron | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0315 | Ondansetron | ondansetron | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0344 | Ondansetron | ondansetron | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-0344 | Ondansetron | ondansetron | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0344 | Ondansetron | ondansetron | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0374 | Ondansetron | ondansetron | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51079-524 | Ondansetron | ondansetron | Mylan Institutional Inc. | ANDA | Current |
| 51079-525 | Ondansetron | ondansetron | Mylan Institutional Inc. | ANDA | Current |
| 55154-5369 | Ondansetron | ondansetron | Cardinal Health | ANDA | Current |