Application 040667
- Type
- ANDA
- Sponsor
- HIKMA INTL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRIMIDONE | PRIMIDONE | TABLET;ORAL | 50MG | No | No |
| 002 | PRIMIDONE | PRIMIDONE | TABLET;ORAL | 250MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-1482 | Primidone | Primidone | West-ward Pharmaceutical Corp | ANDA | Current |
| 0143-1484 | Primidone | Primidone | West-ward Pharmaceutical Corp | ANDA | Current |
| 0615-2521 | Primidone | primidone | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |