FDA NDA · NDA021074

3M AVAGARD

chlorhexidine gluconate and alcohol

Sponsor: SOLVENTUM

APPLICATION

NDA021074

TYPE

NDA

ORIGINAL APPROVAL

2001-06-07

LATEST ACTION

2017-09-06

ROUTE

TOPICAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Over-the-counter

Products

AVAGARD · ReferenceOver-the-counter

ALCOHOL 61%, CHLORHEXIDINE GLUCONATE 1% · SOLUTION · TOPICAL

2017-09-06Labeling · Supplement 12 · standard — Letter ↗AP

2016-11-04Labeling · Supplement 11 · standard — Letter ↗AP

2015-11-12Labeling · Supplement 10 · standard — Letter ↗AP

2013-02-15Labeling · Supplement 9 · standard — Label ↗AP

2012-06-07Labeling · Supplement 8 · unknown — Letter ↗AP

2012-05-17Labeling · Supplement 7 · standard — Letter ↗AP

2002-07-23Manufacturing (CMC) · Supplement 1 · standardAP

2001-06-07Type 3 - New Dosage Form · Original · standard — Letter ↗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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