Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050590
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
TIMENTIN CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
TIMENTIN CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM EQ 1GM BASE/VIAL;EQ 30GM 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
04/01/1985 ORIG-1 Approval Type 4 - New Combination 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
06/12/2014 SUPPL-69 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050590s069,050658s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050590Orig1s069,050658Orig1s031ltr.pdf
02/12/2014 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

09/27/2013 SUPPL-67 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050590s067,050658s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050590Orig1s067,050658Orig1s029ltr.pdf
07/19/2013 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

03/20/2013 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

10/04/2012 SUPPL-62 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050590s062,050658s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050590Orig1s062,050658Orig1s025ltr.pdf
06/09/2011 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050590s060s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050590s060,s061,050658s024ltr.pdf
06/09/2011 SUPPL-60 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050590s060s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050590s060,s061,050658s024ltr.pdf
12/20/2010 SUPPL-59 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050658s023,050590s058,050590s059ltr.pdf
12/20/2010 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050658s023,050590s058,050590s059ltr.pdf
04/17/2008 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050590s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050590s057ltr.pdf
05/08/2008 SUPPL-55 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050590s055, 050658s021ltr.pdf
03/15/2007 SUPPL-54 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050590s054,050658s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050590s054,050658s020ltr.pdf
11/19/2004 SUPPL-52 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50590s052,50658s018ltr.pdf
01/03/2003 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/2002 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

08/16/2001 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/2001 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/2002 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50590s40ltr.pdf
11/19/1999 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1999 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1999 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/29/1997 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/07/1999 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1997 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/11/1997 SUPPL-30 Efficacy-New Patient Population

Label is not available on this site.

02/27/1996 SUPPL-29 Labeling

Label is not available on this site.

04/18/1995 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/2002 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50590S027ltr.pdf
09/16/1994 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1996 SUPPL-25 Labeling

Label is not available on this site.

06/08/1993 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/08/1993 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1993 SUPPL-22 Labeling

Label is not available on this site.

12/01/1987 SUPPL-21 Labeling

Label is not available on this site.

03/26/1992 SUPPL-20 Labeling

Label is not available on this site.

03/26/1992 SUPPL-19 Labeling

Label is not available on this site.

01/02/1992 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1990 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/1991 SUPPL-16 Efficacy-New Indication

Label is not available on this site.

04/20/1989 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1989 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1988 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1988 SUPPL-12 Labeling

Label is not available on this site.

08/18/1987 SUPPL-11 Labeling

Label is not available on this site.

10/23/1987 SUPPL-10 Efficacy-New Indication

Label is not available on this site.

02/14/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1985 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1985 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1985 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1985 SUPPL-3 Labeling

Label is not available on this site.

04/19/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/13/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/12/2014 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050590s069,050658s031lbl.pdf
09/27/2013 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050590s067,050658s029lbl.pdf
10/04/2012 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050590s062,050658s025lbl.pdf
06/09/2011 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050590s060s061lbl.pdf
06/09/2011 SUPPL-60 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050590s060s061lbl.pdf
12/20/2010 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf
12/20/2010 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf
04/17/2008 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050590s057lbl.pdf
03/15/2007 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050590s054,050658s020lbl.pdf

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