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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019824
Company: EUROFARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPROX CICLOPIROX 0.77% SUSPENSION;TOPICAL Prescription AB Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/04/2025 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019824Orig1s025lbl.pdf
11/04/2025 SUPPL-25 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019824Orig1s025lbl.pdf
06/28/2013 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf
03/26/2003 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr009_loprox_lbl.pdf
03/26/2003 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr008_loprox_lbl.pdf
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