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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

Approval history

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
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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