← FDA DRUG APPROVALS

FDA NDA · NDA019258

BACTOSHIELD CHG

chlorhexidine gluconate

Sponsor: ECOLAB

APPLICATION
NDA019258
TYPE
NDA
ORIGINAL APPROVAL
1986-07-22
LATEST ACTION
2018-01-10
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter

Products

CIDA-STATOver-the-counter
CHLORHEXIDINE GLUCONATE 2% · SOLUTION · TOPICAL
CHG SCRUBOver-the-counter
CHLORHEXIDINE GLUCONATE 4% · SOLUTION · TOPICAL

Approval history

2018-01-10Labeling · Supplement 26 · standard — Letter ↗AP
2016-01-14Manufacturing (CMC) · Supplement 23 · standard — Letter ↗AP
2015-12-28Manufacturing (CMC) · Supplement 22 · standardAP
2015-08-05Manufacturing (CMC) · Supplement 21 · standard — Letter ↗AP
2014-12-16Manufacturing (CMC) · Supplement 20 · standardAP
2012-05-17Labeling · Supplement 19 · standard — Letter ↗AP
2010-04-23Labeling · Supplement 16 · standard — Letter ↗AP
2006-04-03Manufacturing (CMC) · Supplement 14 · standard — Letter ↗AP
2005-02-15Manufacturing (CMC) · Supplement 11 · standard — Letter ↗AP
2002-12-20Manufacturing (CMC) · Supplement 13 · standardAP
2002-07-25Manufacturing (CMC) · Supplement 12 · standardAP
2001-04-17Manufacturing (CMC) · Supplement 10 · standardAP
1995-12-08Labeling · Supplement 8 · standardAP
1995-08-16Manufacturing (CMC) · Supplement 9 · standardAP
1993-05-10Manufacturing (CMC) · Supplement 6 · standardAP
1993-05-06Manufacturing (CMC) · Supplement 7 · standardAP
1987-06-02Manufacturing (CMC) · Supplement 2 · standardAP
1986-07-22Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →