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Application 078137
- Type
- ANDA
- Sponsor
- WOCKHARDT
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 |
|---|
| 64679-729 | FOSPHENYTOIN SODIUM | fosphenytoin sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-729 | FOSPHENYTOIN SODIUM | fosphenytoin sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-729 | FOSPHENYTOIN SODIUM | fosphenytoin sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-729 | FOSPHENYTOIN SODIUM | fosphenytoin sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-730 | FOSPHENYTOIN SODIUM | fosphenytoin sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-730 | FOSPHENYTOIN SODIUM | fosphenytoin sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-730 | FOSPHENYTOIN SODIUM | fosphenytoin sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-730 | FOSPHENYTOIN SODIUM | fosphenytoin sodium | Wockhardt USA LLC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39554 | ORIG | 2007-08-07 |
| 9123 | ORIG | 2007-08-07 |