Application 079199
- Type
- ANDA
- Sponsor
- MYLAN INSTITUTIONAL
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 |
|---|
| 67457-228 | Rocuronium Bromide | rocuronium bromide | Mylan Institutional LLC | ANDA | Current |
| 67457-228 | Rocuronium Bromide | rocuronium bromide | Mylan Institutional LLC | ANDA | Current |
| 67457-573 | Rocuronium Bromide | rocuronium bromide | Mylan Institutional LLC | ANDA | Current |
| 67457-574 | Rocuronium Bromide | rocuronium bromide | Mylan Institutional LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9236 | ORIG | 2008-12-02 |