Application 080557
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | CYANOCOBALAMIN | CYANOCOBALAMIN | INJECTABLE;INJECTION | 0.1MG/ML | No | No |
| 003 | VIBISONE | CYANOCOBALAMIN | INJECTABLE;INJECTION | 1MG/ML | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-044 | Cyanocobalamin | CYANOCOBALAMIN | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-044 | Cyanocobalamin | CYANOCOBALAMIN | Fresenius Kabi USA, LLC | ANDA | Current |
| 69263-816 | B12 Inject Kit | Cyanocobalamin | Oaklock, LLC | ANDA | Current |
| 76420-111 | Cyanocobalamin | CYANOCOBALAMIN | Asclemed USA, Inc. | ANDA | Current |