Application 071209
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 5MG | No | No |
| 002 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 0.5MG | No | No |
| 003 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 1MG | No | No |
| 004 | HALOPERIDOL | HALOPERIDOL | TABLET;ORAL | 2MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-1396 | Haloperidol | Haloperidol | Sandoz Inc | ANDA | Current |
| 0781-1396 | Haloperidol | Haloperidol | Sandoz Inc | ANDA | Current |
| 0904-5925 | Haloperidol | Haloperidol | Major Pharmaceuticals | ANDA | Current |
| 21695-653 | Haloperidol | Haloperidol | Rebel Distributors Corp | ANDA | Current |
| 50090-2668 | Haloperidol | Haloperidol | A-S Medication Solutions | ANDA | Current |
| 50090-3365 | Haloperidol | Haloperidol | A-S Medication Solutions | ANDA | Current |
| 53808-0263 | Haloperidol | Haloperidol | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-5414 | Haloperidol | Haloperidol | Cardinal Health | ANDA | Current |
| 63187-842 | Haloperidol | Haloperidol | Proficient Rx LP | ANDA | Current |
| 63187-842 | Haloperidol | Haloperidol | Proficient Rx LP | ANDA | Current |
| 70518-1529 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |
| 70518-1529 | Haloperidol | Haloperidol | REMEDYREPACK INC. | ANDA | Current |