FDA NDA · NDA021669

CHLORHEXIDINE GLUCONATE

Sponsor: SAGE PRODS

APPLICATION

NDA021669

TYPE

NDA

ORIGINAL APPROVAL

2005-04-25

LATEST ACTION

2017-09-06

ROUTE

TOPICAL

DOSAGE FORM

CLOTH

MARKETING STATUS

Over-the-counter

Products

CHLORHEXIDINE GLUCONATE · ReferenceOver-the-counter

CHLORHEXIDINE GLUCONATE 2% · CLOTH · TOPICAL

2017-09-06Labeling · Supplement 23 · standard — Letter ↗AP

2016-06-07Manufacturing (CMC) · Supplement 21 · standardAP

2015-03-16Manufacturing (CMC) · Supplement 20 · standardAP

2014-06-24Labeling · Supplement 19 · standard — Letter ↗AP

2013-11-22Manufacturing (CMC) · Supplement 18 · standardAP

2013-08-30Manufacturing (CMC) · Supplement 17 · standardAP

2012-12-26Manufacturing (CMC) · Supplement 16 · standardAP

2012-05-20Labeling · Supplement 14 · standard — Letter ↗AP

2007-02-01Supplement · Supplement 6 · standard — Review ↗AP

2006-08-17Labeling · Supplement 3 · standard — Label ↗AP

2006-07-24Supplement · Supplement 4 · standardAP

2006-02-17Supplement · Supplement 1 · standardAP

2006-01-13Labeling · Supplement 2 · standard — Letter ↗AP

2005-04-25Type 3 - New Dosage Form · Original · standard — Label ↗AP

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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