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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050591
Company: GLAXOSMITHKLINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACTROBAN MUPIROCIN 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT;TOPICAL Discontinued None Yes No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
12/31/1987 ORIG-1 Approval Type 1 - New Molecular Entity 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
05/08/2017 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050591s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050591Orig1s034ltr.pdf
12/14/2015 SUPPL-33 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050591s033lbl.pdf
05/22/2014 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/50591Orig1s032,50703Orig1s015,50746Orig1s018ltr.pdf
03/19/2015 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050591s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050591Orig1s030ltr.pdf
11/09/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
09/21/2001 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
09/12/2000 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/19/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
04/22/1999 SUPPL-22 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/1999/50591s22ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50591S022_Bactroban.pdf
12/03/1997 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
12/24/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
06/06/1996 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
11/02/1993 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
03/24/1994 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/24/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
02/21/1996 SUPPL-15 Labeling

Label is not available on this site.
04/15/1991 SUPPL-13 Labeling

Label is not available on this site.
09/30/1991 SUPPL-12 Labeling

Label is not available on this site.
04/15/1991 SUPPL-11 Labeling

Label is not available on this site.
04/15/1991 SUPPL-10 Labeling

Label is not available on this site.
04/15/1991 SUPPL-9 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/08/2017 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050591s034lbl.pdf
12/14/2015 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050591s033lbl.pdf
03/19/2015 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050591s030lbl.pdf
05/22/2014 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf
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