Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070981
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL | 0.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/06/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/23/2017 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/06/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/19/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |