Application 090843
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 250MG | No | No |
| 002 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 500MG | 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-064 | Levetiracetam | levetiracetam | Accord Healthcare Inc. | ANDA | Current |
| 16729-064 | Levetiracetam | levetiracetam | Accord Healthcare Inc. | ANDA | Current |
| 16729-064 | Levetiracetam | levetiracetam | Accord Healthcare Inc. | ANDA | Current |
| 16729-065 | Levetiracetam | levetiracetam | Accord Healthcare Inc. | ANDA | Current |
| 16729-065 | Levetiracetam | levetiracetam | Accord Healthcare Inc. | ANDA | Current |
| 16729-065 | Levetiracetam | levetiracetam | Accord Healthcare Inc. | ANDA | Current |
| 16729-066 | Levetiracetam | levetiracetam | Accord Healthcare Inc. | ANDA | Current |
| 16729-066 | Levetiracetam | levetiracetam | Accord Healthcare Inc. | ANDA | Current |
| 16729-066 | Levetiracetam | levetiracetam | Accord Healthcare Inc. | ANDA | Current |
| 16729-067 | Levetiracetam | levetiracetam | Accord Healthcare Inc. | ANDA | Current |
| 16729-067 | Levetiracetam | levetiracetam | Accord Healthcare Inc. | ANDA | Current |
| 16729-067 | Levetiracetam | levetiracetam | Accord Healthcare Inc. | ANDA | Current |
| 50090-3264 | Levetiracetam | levetiracetam | A-S Medication Solutions | ANDA | Current |
| 50090-3264 | Levetiracetam | levetiracetam | A-S Medication Solutions | ANDA | Current |
| 68788-6798 | Levetiracetam | levetiracetam | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6966 | Levetiracetam | levetiracetam | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0197 | Levetiracetam | levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1497 | Levetiracetam | levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 70518-1497 | Levetiracetam | levetiracetam | REMEDYREPACK INC. | ANDA | Current |
| 71335-0048 | Levetiracetam | levetiracetam | Bryant Ranch Prepack | ANDA | Current |
| 71335-0048 | Levetiracetam | levetiracetam | Bryant Ranch Prepack | ANDA | Current |
| 71335-0048 | Levetiracetam | levetiracetam | Bryant Ranch Prepack | ANDA | Current |
| 71335-0093 | Levetiracetam | levetiracetam | Bryant Ranch Prepack | ANDA | Current |
| 71335-0093 | Levetiracetam | levetiracetam | Bryant Ranch Prepack | ANDA | Current |