Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017768
Company: MOLNLYCKE HLTH
Company: MOLNLYCKE HLTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HIBICLENS | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/26/2023 | SUPPL-59 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017768Orig1s059lbl.pdf | |
| 07/26/2023 | SUPPL-59 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017768Orig1s059lbl.pdf | |
| 06/22/2023 | SUPPL-60 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017768Orig1s060lbl.pdf | |
| 02/11/2022 | SUPPL-56 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017768Orig1s056lbl.pdf | |
| 10/21/2021 | SUPPL-55 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017768Orig1s055lbl.pdf | |
| 11/30/2018 | SUPPL-49 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017768Orig1s049lbl.pdf | |
| 10/17/2017 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017768Orig1s044lbl.pdf | |
| 12/09/2015 | SUPPL-42 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017768s042lbl.pdf |
| 06/30/2014 | SUPPL-41 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017768Orig1s041lbl.pdf |