Application 077545
- Type
- ANDA
- Sponsor
- HIKMA INTL PHARMS
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 |
|---|---|---|---|---|---|
| 0143-2422 | Ondansetron | Ondansetron hydrochloride | West-ward Pharmaceutical Corp | ANDA | Current |
| 0143-2423 | Ondansetron | Ondansetron hydrochloride | West-ward Pharmaceutical Corp | ANDA | Current |
| 0143-2424 | Ondansetron | Ondansetron | West-ward Pharmaceutical Corp | ANDA | Current |