Drugs@FDA: FDA-Approved Drugs
Company: ORTHO MCNEIL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALDOL | HALOPERIDOL LACTATE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE;ORAL | Discontinued | None | Yes | No |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 3 - New Dosage Form | 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-66 | Labeling |
Label is not available on this site. |
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| 05/02/2000 | SUPPL-65 | Labeling |
Label is not available on this site. |
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| 05/10/1996 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/23/1998 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/30/1995 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1994 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/07/1989 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/13/1988 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/14/1988 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1986 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/22/1986 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/08/1987 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/11/1983 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 01/31/1983 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 09/08/1982 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 04/20/1982 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1982 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/1981 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/23/1981 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/23/1981 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/19/1980 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/28/1980 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/15/1980 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/06/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 02/12/1980 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 04/12/1979 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1978 | SUPPL-12 | Labeling |
Label is not available on this site. |