Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050746
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACTROBAN MUPIROCIN CALCIUM EQ 2% BASE CREAM;TOPICAL Prescription AB 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
12/11/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050746_bactroban_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/08/2017 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050746s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050746Orig1s021ltr.pdf
12/14/2015 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050746s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050746Orig1s020ltr.pdf
12/16/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/22/2014 SUPPL-18 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-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050746s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050746Orig1s013ltr.pdf
11/15/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/2001 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.

07/14/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/06/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/19/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/10/1998 SUPPL-1 Manufacturing (CMC)-Packaging

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-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050746s021lbl.pdf
12/14/2015 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050746s020lbl.pdf
03/19/2015 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050746s013lbl.pdf
05/22/2014 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf

BACTROBAN

CREAM;TOPICAL; EQ 2% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACTROBAN MUPIROCIN CALCIUM EQ 2% BASE CREAM;TOPICAL Prescription Yes AB 050746 GLAXOSMITHKLINE
MUPIROCIN MUPIROCIN CALCIUM EQ 2% BASE CREAM;TOPICAL Prescription No AB 201587 GLENMARK PHARMS INC

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