Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050788
Company: PADAGIS US

Products on NDA 050788

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CENTANY	MUPIROCIN	2%	OINTMENT;TOPICAL	Prescription	BX	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050788

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50788_Mupirocin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50788ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050788_mupirocin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/19/2015	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050788Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050788Orig1s005ltr.pdf
09/15/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 050788

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/19/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050788Orig1s005lbl.pdf
12/04/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50788_Mupirocin_lbl.pdf

Therapeutic Equivalents for NDA 050788

CENTANY

There are no Therapeutic Equivalents.