Application 202385
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FELBAMATE | FELBAMATE | SUSPENSION;ORAL | 600MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65162-686 | Felbamate | Felbamate | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-686 | Felbamate | Felbamate | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-686 | Felbamate | Felbamate | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-686 | Felbamate | Felbamate | Amneal Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32254 | ORIG | 2011-12-27 |