APPLICATION
ANDA087509
TYPE
ANDA
ORIGINAL APPROVAL
1982-10-05
LATEST ACTION
1998-01-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MEPIVACAINE HYDROCHLORIDEDiscontinued
MEPIVACAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
Approval history
1998-01-14Manufacturing (CMC) · Supplement 8AP
1995-09-19Manufacturing (CMC) · Supplement 10AP
1994-06-28Manufacturing (CMC) · Supplement 9AP
1993-10-29Manufacturing (CMC) · Supplement 7AP
1993-02-08Manufacturing (CMC) · Supplement 6AP
1992-05-07Labeling · Supplement 4AP
1990-08-02Labeling · Supplement 1AP
1990-08-02Labeling · Supplement 2AP
1988-12-13Manufacturing (CMC) · Supplement 3AP
1982-10-05OriginalAP
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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