Application 091458
- Type
- ANDA
- Sponsor
- SAGENT PHARMS INC
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25021-662 | rocuronium bromide | rocuronium bromide | Sagent Pharmaceuticals | ANDA | Current |
| 25021-662 | rocuronium bromide | rocuronium bromide | Sagent Pharmaceuticals | ANDA | Current |
| 25021-662 | rocuronium bromide | rocuronium bromide | Sagent Pharmaceuticals | ANDA | Current |
| 71872-7202 | rocuronium bromide | rocuronium bromide | Medical Purchasing Solutions, LLC | ANDA | Current |