APPLICATION
ANDA088388
TYPE
ANDA
ORIGINAL APPROVAL
1984-10-10
LATEST ACTION
2018-11-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SCANDONEST LDiscontinued
LEVONORDEFRIN 0.05MG/ML, MEPIVACAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
Approval history
2018-11-02Labeling · Supplement 38 · standardAP
2008-09-12Labeling · Supplement 30AP
2007-06-18Labeling · Supplement 29AP
2004-10-12Labeling · Supplement 27AP
2000-04-06Manufacturing (CMC) · Supplement 20AP
2000-04-06Manufacturing (CMC) · Supplement 19AP
1996-03-04Labeling · Supplement 16AP
1994-08-04Manufacturing (CMC) · Supplement 15AP
1993-09-16Labeling · Supplement 14AP
1992-05-12Manufacturing (CMC) · Supplement 13AP
1992-02-07Manufacturing (CMC) · Supplement 11AP
1988-05-05Labeling · Supplement 8AP
1987-06-22Manufacturing (CMC) · Supplement 7AP
1987-04-08Manufacturing (CMC) · Supplement 5AP
1986-01-14Manufacturing (CMC) · Supplement 4AP
1985-09-16Manufacturing (CMC) · Supplement 2AP
1984-10-10OriginalAP
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.