APPLICATION
ANDA088770
TYPE
ANDA
ORIGINAL APPROVAL
1984-11-20
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MEPIVACAINE HYDROCHLORIDEDiscontinued
MEPIVACAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 12AP
1999-02-02Manufacturing (CMC) · Supplement 11AP
1996-12-04Manufacturing (CMC) · Supplement 9AP
1994-06-06Manufacturing (CMC) · Supplement 8AP
1992-04-09Labeling · Supplement 7AP
1989-07-31Manufacturing (CMC) · Supplement 5AP
1989-03-08Bioequivalence · Supplement 2AP
1989-02-01Manufacturing (CMC) · Supplement 3AP
1989-02-01Manufacturing (CMC) · Supplement 4AP
1986-06-11Manufacturing (CMC) · Supplement 1AP
1984-11-20OriginalAP
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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