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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/17/1976 | ORIG-1 | Approval | Type 2 - New Active Ingredient | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/22/2023 | SUPPL-60 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017768Orig1s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017768Orig1s060ltr.pdf | |
| 07/26/2023 | SUPPL-59 | Labeling-Container/Carton Labels, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017768Orig1s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017768Orig1s059ltr.pdf | |
| 02/11/2022 | SUPPL-56 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017768Orig1s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017768Orig1s056ltr.pdf | |
| 10/21/2021 | SUPPL-55 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017768Orig1s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017768Orig1s055ltr.pdf | |
| 11/30/2018 | SUPPL-49 | Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017768Orig1s049lbl.pdf | |
| 08/10/2018 | SUPPL-48 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/17/2017 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017768Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017768Orig1s044ltr.pdf | |
| 12/09/2015 | SUPPL-42 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017768s042lbl.pdf | |
| 06/30/2014 | SUPPL-41 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017768Orig1s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017768Orig1s041ltr.pdf | |
| 05/24/2012 | SUPPL-39 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017768s039ltr.pdf |
| 07/02/2002 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/2001 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/2000 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/20/1999 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/30/1998 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/1994 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/14/1989 | SUPPL-27 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/18/1989 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 05/11/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1988 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/06/1987 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/09/1985 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/1984 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1981 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/10/1981 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1981 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/29/1980 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1987 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/30/1980 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/25/1979 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/18/1979 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/18/1979 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/12/1978 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/06/1978 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1982 | SUPPL-2 | Efficacy |
Label is not available on this site. |
||
| 05/09/1977 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| 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 |
HIBICLENS
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION;TOPICAL; 4%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHG SCRUB | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | No | 019258 | ECOLAB |
| EXIDINE | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | No | 019125 | XTTRIUM |
| HIBICLENS | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | Yes | 017768 | MOLNLYCKE HLTH |