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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050746
Company: GLAXOSMITHKLINE

Products on NDA 050746

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BACTROBAN	MUPIROCIN CALCIUM	EQ 2% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050746

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
02/19/2020	SUPPL-22	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050746s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050746Orig1s022ltr.pdf
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.

Labels for NDA 050746

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/19/2020	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050746s022lbl.pdf
02/19/2020	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050746s022lbl.pdf
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

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