Application 077989
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
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 |
|---|
| 0641-6136 | Fosphenytoin Sodium | Fosphenytoin Sodium | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6136 | Fosphenytoin Sodium | Fosphenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6136 | Fosphenytoin Sodium | Fosphenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6136 | Fosphenytoin Sodium | Fosphenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6137 | Fosphenytoin Sodium | Fosphenytoin Sodium | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6137 | Fosphenytoin Sodium | Fosphenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6137 | Fosphenytoin Sodium | Fosphenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6137 | Fosphenytoin Sodium | Fosphenytoin Sodium | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31317 | ORIG | 2007-08-07 |
| 18472 | ORIG | 2007-08-07 |