FDA NDA · NDA019127

DYNA-HEX 4

chlorhexidine gluconate

Sponsor: XTTRIUM

APPLICATION

NDA019127

TYPE

NDA

ORIGINAL APPROVAL

1984-12-24

LATEST ACTION

2025-05-27

ROUTE

TOPICAL

DOSAGE FORM

AEROSOL, METERED

MARKETING STATUS

Over-the-counter

Products

EXIDINE · ReferenceOver-the-counter

CHLORHEXIDINE GLUCONATE 4% · AEROSOL, METERED · TOPICAL

2025-05-27Labeling · Supplement 27 · standard — Letter ↗AP

2017-09-14Labeling · Supplement 22 · standard — Letter ↗AP

2013-04-11Labeling · Supplement 20 · standard — Letter ↗AP

2012-07-11Manufacturing (CMC) · Supplement 17 · standardAP

2009-06-16Manufacturing (CMC) · Supplement 13 — Letter ↗AP

1997-06-30Manufacturing (CMC) · Supplement 10 · standardAP

1996-04-12Manufacturing (CMC) · Supplement 9 · standardAP

1996-02-13Manufacturing (CMC) · Supplement 8 · standardAP

1995-06-19Manufacturing (CMC) · Supplement 7 · standardAP

1995-06-19Manufacturing (CMC) · Supplement 6 · standardAP

1994-12-15Manufacturing (CMC) · Supplement 5 · standardAP

1988-06-28Manufacturing (CMC) · Supplement 2 · standardAP

1988-03-02Manufacturing (CMC) · Supplement 1 · standardAP

1984-12-24Type 3 - New Dosage Form · Original · standardAP

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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