APPLICATION
ANDA088387
TYPE
ANDA
ORIGINAL APPROVAL
1984-10-10
LATEST ACTION
2018-11-02
ROUTE
SUBMUCOSAL, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SCANDONEST PLAINPrescription
MEPIVACAINE HYDROCHLORIDE 3% · INJECTABLE · INJECTION
Approval history
2018-11-02Labeling · Supplement 38 · standardAP
2017-06-08Manufacturing (CMC) · Supplement 35 · unknownAP
2007-06-18Labeling · Supplement 30AP
2004-10-12Labeling · Supplement 28AP
2003-01-23Labeling · Supplement 26AP
2000-04-06Manufacturing (CMC) · Supplement 19AP
2000-04-06Manufacturing (CMC) · Supplement 20AP
1996-03-04Labeling · Supplement 15AP
1994-08-04Manufacturing (CMC) · Supplement 16AP
1993-09-16Labeling · Supplement 14AP
1992-05-12Manufacturing (CMC) · Supplement 13AP
1992-02-07Manufacturing (CMC) · Supplement 11AP
1989-09-12Manufacturing (CMC) · Supplement 9AP
1989-09-12Manufacturing (CMC) · Supplement 10AP
1988-05-05Labeling · Supplement 8AP
1987-06-17Manufacturing (CMC) · Supplement 7AP
1987-04-08Manufacturing (CMC) · Supplement 5AP
1986-01-14Manufacturing (CMC) · Supplement 4AP
1985-09-10Manufacturing (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.