Application 077096
- Type
- ANDA
- Sponsor
- MEITHEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INTRAVENOUS | 50MG/5ML (10MG/ML) | No | No |
| 002 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INTRAVENOUS | 150MG/15ML (10MG/ML) | No | No |
| 003 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INTRAVENOUS | 450MG/45ML (10MG/ML) | No | No |
| 004 | CARBOPLATIN | CARBOPLATIN | INJECTABLE;INTRAVENOUS | 600MG/60ML (10MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25021-202 | Carboplatin | carboplatin | Sagent Pharmaceuticals | ANDA | Current |
| 25021-202 | Carboplatin | carboplatin | Sagent Pharmaceuticals | ANDA | Current |
| 71288-100 | Carboplatin | Carboplatin | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-100 | Carboplatin | Carboplatin | Meitheal Pharmaceuticals Inc. | ANDA | Current |