Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085786
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription AB 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
11/20/1981 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
07/26/2011 SUPPL-80 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

12/06/2010 SUPPL-79 Labeling-Package Insert

Label is not available on this site.

11/25/2008 SUPPL-78 Labeling

Label is not available on this site.

12/16/2002 SUPPL-73 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/2002 SUPPL-72 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/2001 SUPPL-70 Labeling

Label is not available on this site.

01/10/2002 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2001 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/2001 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1999 SUPPL-65 Labeling

Label is not available on this site.

06/15/1999 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

06/15/1999 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

05/05/1999 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

10/21/1997 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

10/21/1997 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

01/27/1998 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

10/21/1997 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

08/11/1997 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

08/11/1997 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

11/02/1995 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

01/24/1994 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

08/13/1992 SUPPL-53 Labeling

Label is not available on this site.

02/03/1992 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

03/27/1992 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

03/27/1992 SUPPL-50 Labeling

Label is not available on this site.

03/27/1992 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

09/15/1989 SUPPL-48 Labeling

Label is not available on this site.

11/02/1988 SUPPL-47 Labeling

Label is not available on this site.

10/28/1988 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

10/28/1988 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

01/21/1988 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

01/21/1988 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

01/21/1988 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

01/21/1988 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

01/20/1987 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/03/1986 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/16/1986 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/16/1986 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/16/1986 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/09/1985 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/07/1985 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/30/1984 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/29/1983 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/29/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/29/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/08/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/08/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/08/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/03/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/03/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/28/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/15/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TRIFLUOPERAZINE HYDROCHLORIDE

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 040209 MYLAN
TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 085786 SANDOZ

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