Application 212688
- Type
- ANDA
- Sponsor
- OVERSEAS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | TABLET, EXTENDED RELEASE;ORAL | 750MG | No | No |
| 002 | LEVETIRACETAM | LEVETIRACETAM | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55488-0519 | LEVETIRACETAM | LEVETIRACETAM | Changzhou Pharmaceutical Factory | ANDA | Current |
| 81665-100 | LEVETIRACETAM | LEVETIRACETAM | Omnivium Pharmaceuticals LLC | ANDA | Current |