Application 204312
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55150-177 | Levetiracetam | Levetiracetam | AuroMedics Pharma LLC | ANDA | Current |
| 55150-177 | Levetiracetam | Levetiracetam | AuroMedics Pharma LLC | ANDA | Current |
| 55150-177 | Levetiracetam | Levetiracetam | AuroMedics Pharma LLC | ANDA | Current |
| 55150-177 | Levetiracetam | Levetiracetam | AuroMedics Pharma LLC | ANDA | Current |
| 70518-2810 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-2810 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-2810 | Levetiracetam | Levetiracetam | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 19545 | ORIG | 2016-02-11 |
| 10324 | ORIG | 2016-02-03 |