APPLICATION
ANDA088325
TYPE
ANDA
ORIGINAL APPROVAL
1984-07-31
LATEST ACTION
2020-03-19
ROUTE
INFILTRATION, PERINEURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERPrescription
LIDOCAINE HYDROCHLORIDE 0.5% · INJECTABLE · INJECTION
Approval history
2020-03-19Labeling · Supplement 38 · standardAP
2020-03-19Labeling · Supplement 36 · standardAP
2010-04-16Labeling · Supplement 23AP
2005-02-23Labeling · Supplement 14AP
1998-05-05Manufacturing (CMC) · Supplement 11AP
1997-01-16Manufacturing (CMC) · Supplement 9AP
1996-10-03Manufacturing (CMC) · Supplement 10AP
1990-09-10Labeling · Supplement 6AP
1988-12-19Labeling · Supplement 5AP
1987-10-14Manufacturing (CMC) · Supplement 4AP
1986-08-01Manufacturing (CMC) · Supplement 3AP
1986-08-01Manufacturing (CMC) · Supplement 2AP
1985-04-17Manufacturing (CMC) · Supplement 1AP
1984-07-31OriginalAP
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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