Application 209781
- Type
- ANDA
- Sponsor
- HAINAN POLY PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | INJECTABLE;INTRAVENOUS | 500MG/5ML (100MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 14335-050 | Levetiracetam | levetiracetam | Hainan Poly Pharm. Co., Ltd. | ANDA | Current |
| 51224-013 | Levetiracetam | levetiracetam | TAGI Pharma, Inc. | ANDA | Current |
| 51224-013 | Levetiracetam | levetiracetam | TAGI Pharma, Inc. | ANDA | Current |
| 51224-013 | Levetiracetam | levetiracetam | TAGI Pharma, Inc. | ANDA | Current |
| 51224-013 | Levetiracetam | levetiracetam | TAGI Pharma, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53485 | ORIG | 2018-03-28 |