Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201587
Company: GLENMARK PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MUPIROCIN MUPIROCIN CALCIUM EQ 2% BASE CREAM;TOPICAL Prescription None No 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
01/24/2013 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201587Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/16/2019 SUPPL-9 Labeling-Proprietary Name Change

Label is not available on this site.

10/30/2018 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/30/2018 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/30/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/30/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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