Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050703
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACTROBAN MUPIROCIN CALCIUM EQ 2% BASE OINTMENT;NASAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/18/1995 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
05/08/2017 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050703s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050703ORig1s017ltr.pdf
05/14/2015 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050703s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050703Orig1s016ltr.pdf
05/22/2014 SUPPL-15 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
11/15/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/06/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/19/1999 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/03/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1995 SUPPL-1 Manufacturing (CMC)

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-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050703s017lbl.pdf
05/14/2015 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050703s016lbl.pdf
05/22/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf

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