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FDA NDA · NDA019125

ANTISEPTIC SKIN CLEANSER

chlorhexidine gluconate

Sponsor: XTTRIUM

APPLICATION
NDA019125
TYPE
NDA
ORIGINAL APPROVAL
1984-12-24
LATEST ACTION
2026-07-24
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter

Products

DYNA-HEX 4Over-the-counter
CHLORHEXIDINE GLUCONATE 4% · SOLUTION · TOPICAL

Approval history

2026-07-24Labeling · Supplement 50 · standard — Letter ↗AP
2026-02-03Manufacturing (CMC) · Supplement 48 — Label ↗AP
2022-09-29Manufacturing (CMC) · Supplement 45 — Letter ↗AP
2017-09-14Labeling · Supplement 44 · standard — Letter ↗AP
2014-10-17Labeling · Supplement 42 · standard — Letter ↗AP
2012-11-09Labeling · Supplement 40 · standard — Letter ↗AP
2005-05-16Labeling · Supplement 34 · standard — Letter ↗AP
1999-10-08Manufacturing (CMC) · Supplement 31 · standardAP
1999-09-08Manufacturing (CMC) · Supplement 30 · standardAP
1998-09-11Manufacturing (CMC) · Supplement 29 · standardAP
1996-06-06Manufacturing (CMC) · Supplement 28 · standard — Review ↗AP
1996-05-06Manufacturing (CMC) · Supplement 27 · standardAP
1996-04-12Manufacturing (CMC) · Supplement 26 · standardAP
1996-02-21Manufacturing (CMC) · Supplement 25 · standardAP
1996-02-06Manufacturing (CMC) · Supplement 23 · standardAP
1996-02-06Manufacturing (CMC) · Supplement 24 · standardAP
1995-08-28Manufacturing (CMC) · Supplement 21 · standardAP
1995-05-10Manufacturing (CMC) · Supplement 19 · standardAP
1995-05-10Manufacturing (CMC) · Supplement 18 · standardAP
1992-11-06Manufacturing (CMC) · Supplement 17 · standardAP
1991-03-07Manufacturing (CMC) · Supplement 13 · standardAP
1990-01-23Manufacturing (CMC) · Supplement 11 · standardAP
1989-12-27Efficacy · Supplement 4AP
1989-08-14Manufacturing (CMC) · Supplement 10 · standardAP
1988-08-25Manufacturing (CMC) · Supplement 6 · standardAP
1986-06-09Manufacturing (CMC) · Supplement 1 · standardAP
1985-09-04Manufacturing (CMC) · Supplement 3 · standardAP
1984-12-24Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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