APPLICATION
ANDA080925
TYPE
ANDA
ORIGINAL APPROVAL
1972-10-17
LATEST ACTION
1999-08-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ISOCAINE HYDROCHLORIDEDiscontinued
MEPIVACAINE HYDROCHLORIDE 3% · INJECTABLE · INJECTION
Approval history
1999-08-02Manufacturing (CMC) · Supplement 23AP
1993-04-19Labeling · Supplement 22AP
1993-03-11Manufacturing (CMC) · Supplement 19AP
1993-03-11Manufacturing (CMC) · Supplement 21AP
1993-01-26Manufacturing (CMC) · Supplement 20AP
1992-05-05Labeling · Supplement 17AP
1991-05-16Labeling · Supplement 14AP
1991-05-16Manufacturing (CMC) · Supplement 13AP
1990-09-20Labeling · Supplement 16AP
1984-10-10Manufacturing (CMC) · Supplement 11AP
1983-11-07Labeling · Supplement 12AP
1983-06-16Manufacturing (CMC) · Supplement 10AP
1982-10-25Manufacturing (CMC) · Supplement 9AP
1982-08-09Manufacturing (CMC) · Supplement 7AP
1982-05-13Manufacturing (CMC) · Supplement 6AP
1972-10-17OriginalAP
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.
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