← FDA DRUG APPROVALS

FDA NDA · NDA210872

ZURAGARD

Sponsor: ZUREX PHARMA

APPLICATION
NDA210872
TYPE
NDA
ORIGINAL APPROVAL
2019-04-26
LATEST ACTION
2021-06-24
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter

Products

ZURAGARD · ReferenceOver-the-counter
ISOPROPYL ALCOHOL 70% · SOLUTION · TOPICAL

Approval history

2021-06-24Efficacy · Supplement 1 · standardLetterAP
2019-04-26Type 5 - New Formulation or New Manufacturer · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →