Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062691
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMENTIN CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL INJECTABLE;INJECTION 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
12/19/1986 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
06/27/2013 SUPPL-54 Labeling

Label is not available on this site.

06/27/2013 SUPPL-53 Labeling

Label is not available on this site.

03/04/2011 SUPPL-52 Labeling

Label is not available on this site.

02/17/2009 SUPPL-51 Labeling

Label is not available on this site.

06/28/2008 SUPPL-50 Labeling

Label is not available on this site.

06/10/2008 SUPPL-49 Labeling

Label is not available on this site.

07/06/2005 SUPPL-47 Labeling

Label is not available on this site.

10/07/2003 SUPPL-46 Labeling

Label is not available on this site.

10/07/2004 SUPPL-45 Labeling

Label is not available on this site.

02/04/2004 SUPPL-42 Labeling

Label is not available on this site.

12/09/2002 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/2002 SUPPL-33 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/20/2002 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/01/2002 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/2001 SUPPL-29 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/31/2001 SUPPL-28 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/24/2000 SUPPL-22 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/25/1999 SUPPL-21 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/11/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/19/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/29/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/02/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/02/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/02/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/03/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/03/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/13/1996 SUPPL-12 Labeling

Label is not available on this site.

02/23/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/21/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/16/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/16/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/16/1993 SUPPL-6 Labeling

Label is not available on this site.

04/17/1992 SUPPL-5 Labeling

Label is not available on this site.

01/30/1992 SUPPL-4 Labeling

Label is not available on this site.

02/26/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/05/1991 SUPPL-2 Labeling

Label is not available on this site.

04/20/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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