Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071233
Company: VINTAGE
Company: VINTAGE
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 |
---|---|---|---|---|---|---|---|
11/03/1986 | 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 |
---|---|---|---|---|---|
03/18/2015 | SUPPL-16 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/27/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
03/09/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
12/24/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/20/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/15/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/02/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |