Application 091300
- Type
- ANDA
- Sponsor
- APOTEX CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RILUZOLE | RILUZOLE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-3285 | RILUZOLE | RILUZOLE | Apotex Corp | ANDA | Current |
| 60505-3285 | RILUZOLE | RILUZOLE | Apotex Corp | ANDA | Current |
| 60505-3285 | RILUZOLE | RILUZOLE | Apotex Corp | ANDA | Current |
| 68084-908 | RILUZOLE | RILUZOLE | American Health Packaging | ANDA | Current |
| 68084-908 | RILUZOLE | RILUZOLE | American Health Packaging | ANDA | Current |
| 68084-908 | RILUZOLE | RILUZOLE | American Health Packaging | ANDA | Current |