Drugs@FDA: FDA-Approved Drugs
Company: ORTHO MCNEIL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALDOL | HALOPERIDOL | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| HALDOL | HALOPERIDOL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| HALDOL | HALOPERIDOL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| HALDOL | HALOPERIDOL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| HALDOL | HALOPERIDOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| HALDOL | HALOPERIDOL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/12/1967 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/17/2002 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 05/02/2000 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 05/10/1996 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1998 | SUPPL-71 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/30/1995 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1994 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1990 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1988 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1988 | SUPPL-61 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/16/1987 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1986 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/06/1986 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/30/1985 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/30/1985 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1983 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/18/1983 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/18/1983 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/11/1983 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 01/31/1983 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 09/08/1982 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 09/03/1982 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1982 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1982 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/1981 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 01/23/1981 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 01/23/1981 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/07/1980 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/02/1982 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1979 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 02/12/1980 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/12/1977 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1978 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/26/1976 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1974 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1974 | SUPPL-12 | Unspecified |
Label is not available on this site. |