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FDA ANDA · ANDA088390

LIDOCAINE

lidocaine hydrochloride and epinephrine bitartrate

Sponsor: DEPROCO

APPLICATION
ANDA088390
TYPE
ANDA
ORIGINAL APPROVAL
1985-01-22
LATEST ACTION
2025-06-27
ROUTE
SUBMUCOSAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LIGNOSPAN STANDARD · ReferencePrescription
EPINEPHRINE BITARTRATE EQ 0.01MG BASE/ML, LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION

Approval history

2025-06-27Labeling · Supplement 62 · standard — Label ↗AP
2021-06-08Labeling · Supplement 55 · standardAP
2018-11-02Labeling · Supplement 52 · standardAP
2017-07-28Labeling · Supplement 40AP
2007-06-29Labeling · Supplement 35AP
2004-10-04Labeling · Supplement 31AP
2000-04-06Manufacturing (CMC) · Supplement 24AP
2000-04-06Manufacturing (CMC) · Supplement 25AP
1996-03-04Labeling · Supplement 21AP
1994-08-04Manufacturing (CMC) · Supplement 20AP
1993-03-23Manufacturing (CMC) · Supplement 18AP
1993-02-09Manufacturing (CMC) · Supplement 17AP
1992-05-12Manufacturing (CMC) · Supplement 16AP
1992-02-03Manufacturing (CMC) · Supplement 14AP
1992-01-27Manufacturing (CMC) · Supplement 12AP
1988-05-05Labeling · Supplement 9AP
1987-06-08Manufacturing (CMC) · Supplement 8AP
1987-03-16Manufacturing (CMC) · Supplement 6AP
1986-01-14Manufacturing (CMC) · Supplement 5AP
1985-01-22OriginalAP
VIEW ON DRUGS@FDA ↗

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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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