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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018748
Company: MEDIMETRIKS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPROX CICLOPIROX 0.77% CREAM;TOPICAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/28/2013 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf
03/26/2003 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18748slr010_loprox_lbl.pdf
08/17/2001 SUPPL-11 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18748s11lbl.pdf
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