Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050658
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMENTIN IN PLASTIC CONTAINER CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM EQ 100MG BASE/100ML;EQ 3GM BASE/100ML 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
12/15/1989 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

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-31 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
05/14/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/27/2013 SUPPL-29 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
05/29/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/04/2012 SUPPL-25 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-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050658s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050590s060,s061,050658s024ltr.pdf
12/20/2010 SUPPL-23 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-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050658s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050658s022ltr.pdf
05/08/2008 SUPPL-21 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-20 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-18 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-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/17/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

03/18/2002 SUPPL-9 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-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1999 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1996 SUPPL-4 Labeling

Label is not available on this site.

09/15/1994 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1996 SUPPL-2 Labeling

Label is not available on this site.

12/22/1992 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-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050590s069,050658s031lbl.pdf
09/27/2013 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050590s067,050658s029lbl.pdf
10/04/2012 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050590s062,050658s025lbl.pdf
06/09/2011 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050658s024lbl.pdf
12/20/2010 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf
04/17/2008 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050658s022lbl.pdf
03/15/2007 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050590s054,050658s020lbl.pdf

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