Application 216004
- Type
- ANDA
- Sponsor
- MSN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 0.5MG | No | No |
| 002 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 1MG | No | No |
| 003 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 2MG | No | No |
| 004 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 5MG | No | No |
| 005 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 10MG | No | No |
| 006 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72205-064 | HALOPERIDOL | HALOPERIDOL | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-065 | HALOPERIDOL | HALOPERIDOL | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-066 | HALOPERIDOL | HALOPERIDOL | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-067 | HALOPERIDOL | HALOPERIDOL | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-068 | HALOPERIDOL | HALOPERIDOL | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-069 | HALOPERIDOL | HALOPERIDOL | Novadoz Pharmaceuticals LLC | ANDA | Current |