Application 078582
- Type
- ANDA
- Sponsor
- ACI HEALTHCARE LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | SOLUTION;ORAL | 100MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0054-0224 | Levetiracetam | Levetiracetam | Roxane Laboratories, Inc | ANDA | Current |
| 10135-695 | LEVETIRACETAM | levetiracetam | Marlex Pharmaceuticals Inc | ANDA | Current |
| 24689-106 | LEVETIRACETAM | levetiracetam | APNAR PHARMA LP | ANDA | Current |
| 71093-144 | Levetiracetam | Levetiracetam | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-144 | Levetiracetam | Levetiracetam | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-144 | Levetiracetam | Levetiracetam | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-144 | Levetiracetam | Levetiracetam | ACI Healthcare USA, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44388 | ORIG | 2009-02-04 |
| 9169 | ORIG | 2009-01-21 |