Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050605
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTIN CEFUROXIME AXETIL EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CEFTIN CEFUROXIME AXETIL EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CEFTIN CEFUROXIME AXETIL EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
12/28/1987 ORIG-1 Approval Type 2 - New Active Ingredient 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
04/25/2019 SUPPL-51 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050605s051,050672s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/50605Orig1s051; 50672Orig1s037ltr.pdf
10/13/2017 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050605s050,050672s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050605Orig1s050,050672Orig1s36ltr.pdf
11/22/2016 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050605s049,050672s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050605Orig1s049,050672Orig1s035ltr.pdf
08/26/2015 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s048,050672Orig1s034ltr.pdf
06/26/2015 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s047,050672s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s047,050672Orig1s033ltr.pdf
09/20/2014 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050605Orig1s043,s046ltr.pdf
09/20/2014 SUPPL-43 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050605Orig1s043,s046ltr.pdf
07/23/2007 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050605s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050605s042ltr.pdf
06/03/2004 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ceftin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50605slr039,50672slr025ltr.pdf
07/24/2002 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605slr037ltr.pdf
12/20/2001 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/13/2001 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/2001 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/11/2002 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s33ltr.pdf
08/24/1999 SUPPL-32 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50605ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50605S032_Ceftin.pdf
03/29/2002 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s31ltr.pdf
03/24/1998 SUPPL-30 Labeling

Label is not available on this site.

01/16/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

11/19/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/04/1997 SUPPL-27 Labeling

Label is not available on this site.

12/23/1996 SUPPL-26 Labeling

Label is not available on this site.

09/17/1997 SUPPL-25 Efficacy-New Dosing Regimen

Label is not available on this site.

12/06/1996 SUPPL-24 Efficacy-New Indication

Label is not available on this site.

09/13/1996 SUPPL-23 Labeling

Label is not available on this site.

09/13/1996 SUPPL-22 Labeling

Label is not available on this site.

12/23/1996 SUPPL-21 Labeling

Label is not available on this site.

08/30/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/30/1994 SUPPL-19 Labeling

Label is not available on this site.

12/19/1996 SUPPL-17 Efficacy-New Indication

Label is not available on this site.

06/28/1993 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1993 SUPPL-15 Labeling

Label is not available on this site.

01/31/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/27/1993 SUPPL-13 Labeling

Label is not available on this site.

08/09/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/27/1993 SUPPL-11 Labeling

Label is not available on this site.

08/19/1991 SUPPL-9 Labeling

Label is not available on this site.

01/31/1992 SUPPL-8 Efficacy-New Indication

Label is not available on this site.

03/13/1996 SUPPL-7 Efficacy-New Indication

Label is not available on this site.

08/19/1991 SUPPL-6 Labeling

Label is not available on this site.

08/19/1991 SUPPL-5 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/25/2019 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050605s051,050672s037lbl.pdf
04/25/2019 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050605s051,050672s037lbl.pdf
10/13/2017 SUPPL-50 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050605s050,050672s036lbl.pdf
11/22/2016 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050605s049,050672s035lbl.pdf
08/26/2015 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.pdf
06/26/2015 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s047,050672s033lbl.pdf
09/20/2014 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf
09/20/2014 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf
09/20/2014 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf
07/23/2007 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050605s042lbl.pdf
06/03/2004 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ceftin_lbl.pdf
04/11/2002 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf
03/29/2002 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf

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