Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 015921
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HALDOL HALOPERIDOL 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
HALDOL HALOPERIDOL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
HALDOL HALOPERIDOL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
HALDOL HALOPERIDOL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
HALDOL HALOPERIDOL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
HALDOL HALOPERIDOL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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.

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