← FDA DRUG APPROVALS
FDA ANDA · ANDA083158
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%
Sponsor: HOSPIRA
APPLICATION
ANDA083158
TYPE
ANDA
ORIGINAL APPROVAL
1972-10-31
LATEST ACTION
2026-04-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%Discontinued
LIDOCAINE HYDROCHLORIDE 400MG/100ML · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE · ReferenceDiscontinued
LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%Discontinued
LIDOCAINE HYDROCHLORIDE 200MG/100ML · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDEDiscontinued
LIDOCAINE HYDROCHLORIDE 20% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE · ReferenceDiscontinued
LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
Approval history
2026-04-10Labeling · Supplement 115 · standardAP
2021-06-14Manufacturing (CMC) · Supplement 122 · unknownAP
2002-12-03Manufacturing (CMC) · Supplement 96AP
2002-10-25Manufacturing (CMC) · Supplement 95AP
2002-01-02Labeling · Supplement 94AP
1996-10-03Manufacturing (CMC) · Supplement 92AP
1996-09-20Manufacturing (CMC) · Supplement 88AP
1995-11-16Manufacturing (CMC) · Supplement 89AP
1995-11-02Manufacturing (CMC) · Supplement 90AP
1994-10-20Labeling · Supplement 87AP
1994-06-20Manufacturing (CMC) · Supplement 86AP
1991-07-23Labeling · Supplement 85AP
1990-09-20Labeling · Supplement 84AP
1990-09-20Labeling · Supplement 81AP
1990-04-18Labeling · Supplement 80AP
1989-08-04Labeling · Supplement 83AP
1986-08-05Manufacturing (CMC) · Supplement 78AP
1986-02-18Manufacturing (CMC) · Supplement 76AP
1985-08-13Manufacturing (CMC) · Supplement 75AP
1984-10-26Manufacturing (CMC) · Supplement 74AP
1983-05-16Manufacturing (CMC) · Supplement 67AP
1982-09-23Manufacturing (CMC) · Supplement 65AP
1982-07-19Manufacturing (CMC) · Supplement 64AP
1982-06-23Manufacturing (CMC) · Supplement 60AP
1982-06-23Manufacturing (CMC) · Supplement 57AP
1982-06-23Manufacturing (CMC) · Supplement 63AP
1982-06-23Manufacturing (CMC) · Supplement 61AP
1972-10-31OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.