Application 078234
- Type
- ANDA
- Sponsor
- INVAGEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 250MG | No | No |
| 002 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 500MG | No | No |
| 003 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 750MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 53808-0377 | Levetiracetam | Levetiracetam | State of Florida DOH Central Pharmacy | ANDA | Current |
| 76282-246 | Levetiracetam | Levetiracetam | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-247 | Levetiracetam | Levetiracetam | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-248 | Levetiracetam | Levetiracetam | Exelan Pharmaceuticals, Inc. | ANDA | Current |