Application 211002
- Type
- ANDA
- Sponsor
- MEITHEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM | SOLUTION;INTRAVENOUS | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | No | No |
| 002 | LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM | SOLUTION;INTRAVENOUS | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71288-105 | Levoleucovorin | levoleucovorin calcium | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-105 | Levoleucovorin | levoleucovorin calcium | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-105 | Levoleucovorin | levoleucovorin calcium | Meitheal Pharmaceuticals Inc. | ANDA | Current |