APPLICATION
ANDA088653
TYPE
ANDA
ORIGINAL APPROVAL
1984-08-21
LATEST ACTION
2019-01-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
POLOCAINEDiscontinued
MEPIVACAINE HYDROCHLORIDE 3% · INJECTABLE · INJECTION
Approval history
2019-01-15Labeling · Supplement 12 · standardAP
2001-03-30Manufacturing (CMC) · Supplement 8AP
1998-09-29Manufacturing (CMC) · Supplement 6AP
1996-05-31Manufacturing (CMC) · Supplement 5AP
1993-12-13Labeling · Supplement 4AP
1992-09-18Manufacturing (CMC) · Supplement 3AP
1989-02-08Labeling · Supplement 2AP
1985-06-07Manufacturing (CMC) · Supplement 1AP
1984-08-21OriginalAP
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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