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Application 078736
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FOSPHENYTOIN SODIUM | FOSPHENYTOIN SODIUM | INJECTABLE;INJECTION | EQ 50MG PHENYTOIN NA/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67457-516 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-516 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-516 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-516 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-516 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-516 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-516 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-517 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-517 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-517 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-517 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-517 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-517 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |
| 67457-517 | Fosphenytoin Sodium | Fosphenytoin Sodium | Mylan Institutional LLC | ANDA | Current |