← FDA DRUG APPROVALS

FDA NDA · NDA017768

HIBICLENS

chlorhexidine gluconate

Sponsor: MOLNLYCKE HLTH

APPLICATION
NDA017768
TYPE
NDA
ORIGINAL APPROVAL
1976-09-17
LATEST ACTION
2025-10-29
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter

Products

HIBICLENS · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 4% · SOLUTION · TOPICAL

Approval history

2025-10-29Labeling · Supplement 63 · standard — Letter ↗AP
2023-07-26Labeling · Supplement 59 · standard — Letter ↗AP
2023-06-22Manufacturing (CMC) · Supplement 60 — Letter ↗AP
2022-02-11Labeling · Supplement 56 · standard — Letter ↗AP
2021-10-21Manufacturing (CMC) · Supplement 55 — Letter ↗AP
2018-11-30Labeling · Supplement 49 · standard — Label ↗AP
2018-08-10Manufacturing (CMC) · Supplement 48AP
2017-10-17Labeling · Supplement 44 · standard — Letter ↗AP
2015-12-09Manufacturing (CMC) · Supplement 42 · priority — Label ↗AP
2014-06-30Labeling · Supplement 41 · standard — Letter ↗AP
2012-05-24Labeling · Supplement 39 · standard — Letter ↗AP
2002-07-02Manufacturing (CMC) · Supplement 33 · priorityAP
2001-12-12Manufacturing (CMC) · Supplement 32 · priorityAP
2000-02-23Manufacturing (CMC) · Supplement 31 · priorityAP
1999-10-20Manufacturing (CMC) · Supplement 30 · priorityAP
1998-09-30Manufacturing (CMC) · Supplement 29 · priorityAP
1994-03-30Manufacturing (CMC) · Supplement 28 · priorityAP
1989-08-25Labeling · Supplement 25AP
1989-07-18Manufacturing (CMC) · Supplement 26 · priorityAP
1989-07-14Manufacturing (CMC) · Supplement 27 · priorityAP
1988-05-11Manufacturing (CMC) · Supplement 24 · priorityAP
1988-03-03Labeling · Supplement 23AP
1987-05-20Labeling · Supplement 11AP
1987-04-06Manufacturing (CMC) · Supplement 22 · priorityAP
1985-05-09Manufacturing (CMC) · Supplement 19 · priorityAP
1984-06-18Manufacturing (CMC) · Supplement 17 · priorityAP
1982-03-01Efficacy · Supplement 2AP
1981-07-21Manufacturing (CMC) · Supplement 15 · priorityAP
1981-07-06Labeling · Supplement 5AP
1981-03-10Manufacturing (CMC) · Supplement 14 · priorityAP
1981-01-16Manufacturing (CMC) · Supplement 13 · priorityAP
1980-12-29Manufacturing (CMC) · Supplement 12 · priorityAP
1980-07-30Manufacturing (CMC) · Supplement 10 · priorityAP
1979-12-18Manufacturing (CMC) · Supplement 6 · priorityAP
1979-12-18Manufacturing (CMC) · Supplement 7 · priorityAP
1979-07-25Manufacturing (CMC) · Supplement 8 · priorityAP
1978-05-12Manufacturing (CMC) · Supplement 4 · priorityAP
1978-01-06Manufacturing (CMC) · Supplement 3 · priorityAP
1977-05-09Manufacturing (CMC) · Supplement 1 · priorityAP
1976-09-17Type 2 - New Active Ingredient · Original · priorityAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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