Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065085
Company: TEVA
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
11/07/2003 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065085.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/28/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/28/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

02/26/2004 SUPPL-1 Labeling

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 PERRIGO 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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