Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 015922
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HALDOL HALOPERIDOL LACTATE EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CONCENTRATE;ORAL Discontinued None No No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
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.

05/02/2000 SUPPL-65 Labeling

Label is not available on this site.

05/10/1996 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

04/23/1998 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1995 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

06/29/1994 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1989 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

04/13/1988 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

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.

03/11/1983 SUPPL-28 Labeling

Label is not available on this site.

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.

07/06/1979 SUPPL-15 Labeling

Label is not available on this site.

02/12/1980 SUPPL-14 Labeling

Label is not available on this site.

04/12/1979 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/13/1978 SUPPL-12 Labeling

Label is not available on this site.

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