Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071208
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL HALOPERIDOL 2MG 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
11/17/1986 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
02/23/2017 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

12/06/2010 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

07/16/2009 SUPPL-27 Labeling

Label is not available on this site.

09/08/2008 SUPPL-26 Labeling

Label is not available on this site.

05/29/2008 SUPPL-23 Labeling

Label is not available on this site.

04/02/2008 SUPPL-22 Labeling

Label is not available on this site.

09/05/2002 SUPPL-20 Labeling

Label is not available on this site.

05/09/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/2001 SUPPL-17 Labeling

Label is not available on this site.

10/31/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/06/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/21/1998 SUPPL-12 Labeling

Label is not available on this site.

09/21/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/02/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/20/1990 SUPPL-9 Labeling

Label is not available on this site.

04/04/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/01/1989 SUPPL-7 Labeling

Label is not available on this site.

09/09/1988 SUPPL-6 Labeling

Label is not available on this site.

10/28/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/28/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/28/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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