Application 215363
- Type
- ANDA
- Sponsor
- MSN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIGABATRIN | VIGABATRIN | FOR SOLUTION;ORAL | 500MG/PACKET | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72205-093 | Vigabatrin | vigabatrin | Novadoz Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76267 | ORIG | 2023-11-03 |