Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200854
Company: ACTAVIS GROUP
Company: ACTAVIS GROUP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| HALOPERIDOL | HALOPERIDOL | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| HALOPERIDOL | HALOPERIDOL | 2MG | TABLET;ORAL | Discontinued | None | No | No |
| HALOPERIDOL | HALOPERIDOL | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| HALOPERIDOL | HALOPERIDOL | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| HALOPERIDOL | HALOPERIDOL | 20MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/01/2022 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/22/2025 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |