Application 090906
- Type
- ANDA
- Sponsor
- LOTUS PHARM CO LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 500MG | No | No |
| 002 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 250MG | No | No |
| 003 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 750MG | No | No |
| 004 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 1GM | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 13811-621 | LEVETIRACETAM | Levetiracetam | Trigen Laboratories, Inc. | ANDA | Current |
| 40051-135 | LEVETIRACETAM | levetiracetam | Lotus Pharmaceutical Co., Ltd. Nantou Plant | ANDA | Current |
| 40051-136 | LEVETIRACETAM | levetiracetam | Lotus Pharmaceutical Co., Ltd. Nantou Plant | ANDA | Current |
| 40051-137 | LEVETIRACETAM | levetiracetam | Lotus Pharmaceutical Co., Ltd. Nantou Plant | ANDA | Current |
| 40051-138 | LEVETIRACETAM | levetiracetam | Lotus Pharmaceutical Co., Ltd. Nantou Plant | ANDA | Current |
| 53808-1042 | LEVETIRACETAM | Levetiracetam | State of Florida DOH Central Pharmacy | ANDA | Current |
| 69102-101 | ROWEEPRA | levetiracetam | OWP Pharmaceuticals, Inc. | ANDA | Current |
| 69102-102 | ROWEEPRA | levetiracetam | OWP Pharmaceuticals, Inc. | ANDA | Current |
| 69102-103 | ROWEEPRA | levetiracetam | OWP Pharmaceuticals, Inc. | ANDA | Current |
| 69102-104 | ROWEEPRA | levetiracetam | OWP Pharmaceuticals, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 69681 | SUPPL | 2021-12-20 |