APPLICATION
ANDA088571
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-13
LATEST ACTION
2026-04-01
ROUTE
EPIDURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEPrescription
EPINEPHRINE 0.005MG/ML, LIDOCAINE HYDROCHLORIDE 1.5% · INJECTABLE · INJECTION
Approval history
2026-04-01Labeling · Supplement 37 · standardAP
2020-07-15Labeling · Supplement 28 · standardAP
2020-07-15Labeling · Supplement 30 · standardAP
2010-04-09Labeling · Supplement 17AP
2002-12-27Labeling · Supplement 6AP
2002-01-02Labeling · Supplement 7AP
1991-02-15Labeling · Supplement 5AP
1989-05-10Manufacturing (CMC) · Supplement 4AP
1987-05-07Manufacturing (CMC) · Supplement 2AP
1985-09-13OriginalAP
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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