Application 205130
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
| 002 | LEVETIRACETAM | LEVETIRACETAM | TABLET, EXTENDED RELEASE;ORAL | 750MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50228-189 | Levetiracetam | levetiracetam | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-189 | Levetiracetam | levetiracetam | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-190 | Levetiracetam | levetiracetam | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-190 | Levetiracetam | levetiracetam | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 69367-332 | Levetiracetam | Levetiracetam | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-333 | Levetiracetam | Levetiracetam | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 71205-728 | Levetiracetam | Levetiracetam | Proficient Rx LP | ANDA | Current |
| 71205-880 | Levetiracetam | Levetiracetam | Proficient Rx LP | ANDA | Current |
| 71205-880 | Levetiracetam | Levetiracetam | Proficient Rx LP | ANDA | Current |
| 71205-881 | Levetiracetam | Levetiracetam | Proficient Rx LP | ANDA | Current |
| 71205-881 | Levetiracetam | Levetiracetam | Proficient Rx LP | ANDA | Current |