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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019422
Company: XTTRIUM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DYNA-HEX 2 CHLORHEXIDINE GLUCONATE 2% SOLUTION;TOPICAL Over-the-counter None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/25/2026 SUPPL-56 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019422s056lbl.pdf
07/25/2026 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019422s056lbl.pdf
02/03/2026 SUPPL-55 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019422Orig1s055lbl.pdf
01/25/2019 SUPPL-49 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019422Orig1s049Lbl.pdf
12/12/2012 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019422Orig1s043lbl.pdf
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