← FDA DRUG APPROVALS

FDA NDA · NDA019422

FOAMING HAND WASH

chlorhexidine gluconate

Sponsor: XTTRIUM

APPLICATION
NDA019422
TYPE
NDA
ORIGINAL APPROVAL
1985-12-17
LATEST ACTION
2026-07-25
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter

Products

DYNA-HEX 2 · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2% · SOLUTION · TOPICAL

Approval history

2026-07-25Labeling · Supplement 56 · standard — Label ↗AP
2026-02-03Labeling · Supplement 55 · standard — Label ↗AP
2019-01-25Manufacturing (CMC) · Supplement 49 · standard — Label ↗AP
2017-09-15Labeling · Supplement 47 · standard — Letter ↗AP
2016-04-11Manufacturing (CMC) · Supplement 46 · standardAP
2016-03-24Manufacturing (CMC) · Supplement 45 · standardAP
2012-12-12Labeling · Supplement 43 · standard — Letter ↗AP
2009-02-25Manufacturing (CMC) · Supplement 36 — Letter ↗AP
2009-02-25Manufacturing (CMC) · Supplement 37 — Letter ↗AP
2004-12-20Manufacturing (CMC) · Supplement 33 · standard — Letter ↗AP
2003-12-19Efficacy · Supplement 32 · standard — Review ↗AP
2000-03-29Manufacturing (CMC) · Supplement 28 · standardAP
1999-10-08Manufacturing (CMC) · Supplement 29 · standardAP
1998-10-19Manufacturing (CMC) · Supplement 27 · standardAP
1998-09-30Manufacturing (CMC) · Supplement 26 · standardAP
1998-01-08Manufacturing (CMC) · Supplement 25 · standardAP
1997-04-17Manufacturing (CMC) · Supplement 24 · standardAP
1997-03-11Manufacturing (CMC) · Supplement 23 · standardAP
1996-05-06Manufacturing (CMC) · Supplement 22 · standardAP
1996-04-03Manufacturing (CMC) · Supplement 21 · standardAP
1996-02-12Manufacturing (CMC) · Supplement 20 · standardAP
1996-02-06Manufacturing (CMC) · Supplement 18 · standardAP
1996-02-06Manufacturing (CMC) · Supplement 19 · standardAP
1995-05-10Manufacturing (CMC) · Supplement 16 · standardAP
1995-05-10Manufacturing (CMC) · Supplement 17 · standardAP
1992-11-06Manufacturing (CMC) · Supplement 15 · standardAP
1989-12-27Efficacy · Supplement 1AP
1989-07-28Manufacturing (CMC) · Supplement 9 · standardAP
1988-08-12Manufacturing (CMC) · Supplement 7 · standardAP
1988-06-28Manufacturing (CMC) · Supplement 6 · standardAP
1988-04-12Manufacturing (CMC) · Supplement 5 · standardAP
1988-03-02Manufacturing (CMC) · Supplement 2 · standardAP
1987-09-16Manufacturing (CMC) · Supplement 3 · standardAP
1987-09-16Manufacturing (CMC) · Supplement 4 · standardAP
1985-12-17Type 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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