Application 017768
- Type
- NDA
- Sponsor
- MOLNLYCKE HLTH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HIBICLENS | CHLORHEXIDINE GLUCONATE | SOLUTION;TOPICAL | 4% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0234-0575 | Hibiclens | Chlorhexidine Gluconate | Molnlycke Health Care | NDA | Current |
| 0234-0575 | Hibiclens | Chlorhexidine Gluconate | Molnlycke Health Care | NDA | Current |
| 0234-0575 | Hibiclens | Chlorhexidine Gluconate | Molnlycke Health Care | NDA | Current |
| 0234-0575 | Hibiclens | Chlorhexidine Gluconate | Molnlycke Health Care | NDA | Current |
| 0234-0575 | Hibiclens | Chlorhexidine Gluconate | Molnlycke Health Care | NDA | Current |
| 0234-0575 | Hibiclens | Chlorhexidine Gluconate | Molnlycke Health Care | NDA | Current |
| 0234-0575 | Hibiclens | Chlorhexidine Gluconate | Molnlycke Health Care | NDA | Current |
| 0234-0575 | Hibiclens | Chlorhexidine Gluconate | Molnlycke Health Care | NDA | Current |
| 0234-0575 | Hibiclens | Chlorhexidine Gluconate | Molnlycke Health Care | NDA | Current |
| 0234-0575 | Hibiclens | Chlorhexidine Gluconate | Molnlycke Health Care | NDA | Current |
| 0234-0575 | Hibiclens | Chlorhexidine Gluconate | Molnlycke Health Care | NDA | Current |
| 0234-0575 | Hibiclens | Chlorhexidine Gluconate | Molnlycke Health Care | NDA | Current |
| 50090-2354 | Hibiclens | Chlorhexidine Gluconate | A-S Medication Solutions | NDA | Current |
| 50090-2354 | Hibiclens | Chlorhexidine Gluconate | A-S Medication Solutions | NDA | Current |
| 54622-575 | Hibiclens for Georgia Pacific | Chlorhexidine Gluconate | Georgia-Pacific Consumer Products LP | NDA | Current |
| 54622-575 | Hibiclens for Georgia Pacific | Chlorhexidine Gluconate | Georgia-Pacific Consumer Products LP | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84033 | SUPPL | 2025-11-03 |
| 84005 | SUPPL | 2025-10-31 |
| 74933 | SUPPL | 2023-07-31 |
| 74920 | SUPPL | 2023-07-28 |
| 74618 | SUPPL | 2023-06-23 |
| 74611 | SUPPL | 2023-06-23 |
| 70170 | SUPPL | 2022-02-15 |
| 70162 | SUPPL | 2022-02-15 |
| 69954 | SUPPL | 2022-01-24 |
| 69952 | SUPPL | 2022-01-24 |
| 57052 | SUPPL | 2018-12-30 |
| 50144 | SUPPL | 2017-10-23 |
| 50115 | SUPPL | 2017-10-19 |
| 11060 | SUPPL | 2015-12-15 |
| 33342 | SUPPL | 2014-07-31 |
| 698 | SUPPL | 2014-07-01 |
| 13898 | SUPPL | 2012-05-29 |