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FDA ANDA · ANDA040057

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Sponsor: EASTMAN KODAK

APPLICATION
ANDA040057
TYPE
ANDA
ORIGINAL APPROVAL
1993-02-26
LATEST ACTION
2001-01-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEDiscontinued
EPINEPHRINE 0.01MG/ML, LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEDiscontinued
EPINEPHRINE 0.02MG/ML, LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION

Approval history

2001-01-25Manufacturing (CMC) · Supplement 5AP
1999-06-21Manufacturing (CMC) · Supplement 4AP
1996-04-25Manufacturing (CMC) · Supplement 2AP
1995-12-01Manufacturing (CMC) · Supplement 3AP
1993-04-01Labeling · Supplement 1AP
1993-02-26OriginalAP
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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