APPLICATION
ANDA080408
TYPE
ANDA
ORIGINAL APPROVAL
1972-09-28
LATEST ACTION
2020-03-19
ROUTE
EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
LIDOCAINE HYDROCHLORIDE 1.5% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
Approval history
2020-03-19Labeling · Supplement 61 · standardAP
2020-03-19Labeling · Supplement 58 · standardAP
2010-04-16Labeling · Supplement 48AP
2002-01-02Labeling · Supplement 31AP
1997-02-24Manufacturing (CMC) · Supplement 30AP
1996-10-03Manufacturing (CMC) · Supplement 29AP
1990-09-28Labeling · Supplement 26AP
1989-06-13Manufacturing (CMC) · Supplement 27AP
1988-11-28Labeling · Supplement 25AP
1986-07-25Manufacturing (CMC) · Supplement 24AP
1985-08-09Manufacturing (CMC) · Supplement 23AP
1982-09-14Manufacturing (CMC) · Supplement 21AP
1982-09-14Manufacturing (CMC) · Supplement 20AP
1972-09-28OriginalAP
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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