Application 040732
- Type
- ANDA
- Sponsor
- WOCKHARDT USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | CAPSULE;ORAL | 100MG EXTENDED | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55289-906 | EXTENDED PHENYTOIN SODIUM | EXTENDED PHENYTOIN SODIUM | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55648-720 | EXTENDED PHENYTOIN SODIUM | EXTENDED PHENYTOIN SODIUM | Wockhardt Limited | ANDA | Current |
| 64679-720 | EXTENDED PHENYTOIN SODIUM | EXTENDED PHENYTOIN SODIUM | Wockhardt USA LLC. | ANDA | Current |
| 64725-0720 | EXTENDED PHENYTOIN SODIUM | EXTENDED PHENYTOIN SODIUM | TYA Pharmaceuticals | ANDA | Current |