← FDA DRUG APPROVALS

FDA ANDA · ANDA203082

LIDOCAINE HYDROCHLORIDE

Sponsor: EUGIA PHARMA

APPLICATION
ANDA203082
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-14
LATEST ACTION
2019-10-29
ROUTE
EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION

Approval history

2019-10-29Labeling · Supplement 6 · standardAP
2013-03-14UNKNOWN · OriginalAP
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 →