APPLICATION
ANDA089644
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-21
LATEST ACTION
2026-04-01
ROUTE
INFILTRATION, PERINEURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEPrescription
EPINEPHRINE 0.01MG/ML, LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
Approval history
2026-04-01Labeling · Supplement 52 · standardAP
2020-07-15Labeling · Supplement 31 · standardAP
2020-07-15Labeling · Supplement 34 · standardAP
2010-04-12Labeling · Supplement 18AP
2002-09-03Manufacturing (CMC) · Supplement 8AP
2002-01-02Labeling · Supplement 7AP
1998-05-26Manufacturing (CMC) · Supplement 5AP
1998-05-26Manufacturing (CMC) · Supplement 6AP
1997-09-26Manufacturing (CMC) · Supplement 4AP
1990-11-09Labeling · Supplement 3AP
1990-03-21Labeling · Supplement 2AP
1989-07-06Manufacturing (CMC) · Supplement 1AP
1988-06-21OriginalAP
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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