Application 205102
- Type
- ANDA
- Sponsor
- SECAN 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 | 750MG | No | No |
| 003 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 1GM | No | No |
| 004 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43489-122 | Levetiracetam | levetiracetam | Secan Pharmaceuticals, Inc. | ANDA | Current |
| 43489-122 | Levetiracetam | levetiracetam | China Resources Saike Pharmaceutical Co., Ltd. | ANDA | Current |
| 43489-122 | Levetiracetam | levetiracetam | China Resources Saike Pharmaceutical Co., Ltd. | ANDA | Current |
| 43489-124 | Levetiracetam | levetiracetam | Secan Pharmaceuticals, Inc. | ANDA | Current |
| 43489-124 | Levetiracetam | levetiracetam | China Resources Saike Pharmaceutical Co., Ltd. | ANDA | Current |
| 43489-124 | Levetiracetam | levetiracetam | China Resources Saike Pharmaceutical Co., Ltd. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69645 | ORIG | 2021-12-20 |