APPLICATION
ANDA088328
TYPE
ANDA
ORIGINAL APPROVAL
1984-05-17
LATEST ACTION
2020-03-19
ROUTE
INFILTRATION, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 0.5% · INJECTABLE · INJECTION
Approval history
2020-03-19Labeling · Supplement 29 · standardAP
2020-03-19Labeling · Supplement 30 · standardAP
2010-04-16Labeling · Supplement 17AP
1996-10-22Manufacturing (CMC) · Supplement 7AP
1996-10-03Manufacturing (CMC) · Supplement 8AP
1990-10-10Labeling · Supplement 4AP
1988-12-12Labeling · Supplement 3AP
1986-08-15Manufacturing (CMC) · Supplement 2AP
1985-04-18Manufacturing (CMC) · Supplement 1AP
1984-05-17OriginalAP
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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