Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090480
Company: GLENMARK PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MUPIROCIN MUPIROCIN 2% OINTMENT;TOPICAL Prescription AB No 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
06/08/2011 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/04/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

08/04/2021 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

01/05/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/05/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

MUPIROCIN

OINTMENT;TOPICAL; 2%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MUPIROCIN MUPIROCIN 2% OINTMENT;TOPICAL Prescription No AB 065192 FOUGERA PHARMS
MUPIROCIN MUPIROCIN 2% OINTMENT;TOPICAL Prescription No AB 090480 GLENMARK PHARMS
MUPIROCIN MUPIROCIN 2% OINTMENT;TOPICAL Prescription No AB 065123 PADAGIS ISRAEL
MUPIROCIN MUPIROCIN 2% OINTMENT;TOPICAL Prescription No AB 065170 TARO
MUPIROCIN MUPIROCIN 2% OINTMENT;TOPICAL Prescription No AB 065085 TEVA

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