Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019125
Company: XTTRIUM
Company: XTTRIUM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DYNA-HEX 4 | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/03/2026 | SUPPL-48 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019125Orig1s048lbl.pdf | |
| 09/29/2022 | SUPPL-45 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019125Orig1s045lbl.pdf | |
| 09/14/2017 | SUPPL-44 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019125Orig1s044lbl.pdf | |
| 10/17/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019125Orig1s042lbl.pdf |