Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071529
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIOTHIXENE THIOTHIXENE 5MG CAPSULE;ORAL Discontinued None No No
THIOTHIXENE THIOTHIXENE 1MG CAPSULE;ORAL Discontinued None No No
THIOTHIXENE THIOTHIXENE 2MG CAPSULE;ORAL Discontinued None No No
THIOTHIXENE THIOTHIXENE 10MG CAPSULE;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
06/24/1987 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
11/08/2011 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

01/06/2010 SUPPL-20 Labeling-Container/Carton Labels

Label is not available on this site.

10/30/2008 SUPPL-19 Labeling

Label is not available on this site.

05/22/2008 SUPPL-18 Labeling

Label is not available on this site.

05/22/2008 SUPPL-17 Labeling

Label is not available on this site.

12/31/2007 SUPPL-16 Labeling

Label is not available on this site.

07/30/2003 SUPPL-14 Labeling

Label is not available on this site.

08/29/2002 SUPPL-13 Labeling

Label is not available on this site.

11/06/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/25/1998 SUPPL-8 Labeling

Label is not available on this site.

09/25/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/18/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/03/1991 SUPPL-4 Labeling

Label is not available on this site.

11/08/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/17/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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