APPLICATION
ANDA088329
TYPE
ANDA
ORIGINAL APPROVAL
1984-05-17
LATEST ACTION
2020-03-19
ROUTE
EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
Approval history
2020-03-19Labeling · Supplement 40 · standardAP
2020-03-19Labeling · Supplement 41 · standardAP
2010-04-16Labeling · Supplement 28AP
2002-10-25Manufacturing (CMC) · Supplement 19AP
2001-03-22Manufacturing (CMC) · Supplement 18AP
2001-03-22Manufacturing (CMC) · Supplement 17AP
2000-01-07Labeling · Supplement 16AP
2000-01-07Manufacturing (CMC) · Supplement 15AP
1998-05-05Manufacturing (CMC) · Supplement 14AP
1997-01-16Manufacturing (CMC) · Supplement 12AP
1996-10-03Manufacturing (CMC) · Supplement 13AP
1995-01-26Manufacturing (CMC) · Supplement 10AP
1994-07-26Manufacturing (CMC) · Supplement 9AP
1991-02-05Labeling · Supplement 4AP
1990-11-20Manufacturing (CMC) · Supplement 7AP
1990-11-20Manufacturing (CMC) · Supplement 6AP
1988-12-23Labeling · Supplement 3AP
1986-08-15Manufacturing (CMC) · Supplement 2AP
1985-04-16Manufacturing (CMC) · Supplement 1AP
1984-05-17OriginalAP
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.