Application 078651
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | INJECTABLE;INJECTION | 50MG/5ML (10MG/ML) | No | No |
| 002 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | INJECTABLE;INJECTION | 100MG/10ML (10MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-426 | Rocuronium | ROCURONIUM BROMIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-426 | Rocuronium | ROCURONIUM BROMIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-426 | Rocuronium | ROCURONIUM BROMIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-426 | Rocuronium | ROCURONIUM BROMIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-426 | Rocuronium | ROCURONIUM BROMIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-426 | Rocuronium | ROCURONIUM BROMIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-065 | Rocuronium | ROCURONIUM BROMIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65293-426 | Rocuronium | ROCURONIUM BROMIDE | The Medicines Company | ANDA | Current |
| 65293-426 | Rocuronium | ROCURONIUM BROMIDE | The Medicines Company | ANDA | Current |
| 65293-427 | Rocuronium | ROCURONIUM BROMIDE | The Medicines Company | ANDA | Current |
| 65293-427 | Rocuronium | ROCURONIUM BROMIDE | The Medicines Company | ANDA | Current |
| 81565-204 | Rocuronium | ROCURONIUM BROMIDE | Phlow Corporation | ANDA | Current |