Application 078811
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OXALIPLATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/10ML (5MG/ML) | No | No |
| 002 | OXALIPLATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/20ML (5MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-750 | Oxaliplatin | Oxaliplatin | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-750 | Oxaliplatin | Oxaliplatin | Fresenius Kabi USA, LLC | ANDA | Current |