APPLICATION
ANDA089517
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-14
LATEST ACTION
2019-01-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
POLOCAINE W/ LEVONORDEFRINDiscontinued
LEVONORDEFRIN 0.05MG/ML, MEPIVACAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
Approval history
2019-01-15Labeling · Supplement 6 · standardAP
1996-05-31Manufacturing (CMC) · Supplement 4AP
1993-12-13Labeling · Supplement 3AP
1993-02-19Manufacturing (CMC) · Supplement 2AP
1992-09-18Manufacturing (CMC) · Supplement 1AP
1988-04-14OriginalAP
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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