← FDA DRUG APPROVALS

FDA NDA · NDA207964

READYPREP CHG

chlorhexidine gluconate 2%

Sponsor: MEDLINE INDUSTRIES

APPLICATION
NDA207964
TYPE
NDA
ORIGINAL APPROVAL
2018-11-20
LATEST ACTION
2023-05-24
ROUTE
TOPICAL
DOSAGE FORM
CLOTH
MARKETING STATUS
Over-the-counter

Products

READYPREP CHG · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2% · CLOTH · TOPICAL

Approval history

2023-05-24Manufacturing (CMC) · Supplement 3 — Label ↗AP
2018-11-20Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
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 →