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FDA ANDA · ANDA086402

LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE

Sponsor: INTL MEDICATION

APPLICATION
ANDA086402
TYPE
ANDA
ORIGINAL APPROVAL
1980-02-04
LATEST ACTION
1998-01-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINEDiscontinued
EPINEPHRINE 0.01MG/ML, LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION

Approval history

1998-01-14Manufacturing (CMC) · Supplement 18AP
1995-09-19Manufacturing (CMC) · Supplement 21AP
1994-06-17Manufacturing (CMC) · Supplement 20AP
1993-10-29Manufacturing (CMC) · Supplement 17AP
1993-10-15Labeling · Supplement 19AP
1993-08-30Manufacturing (CMC) · Supplement 15AP
1993-02-08Manufacturing (CMC) · Supplement 13AP
1993-02-08Manufacturing (CMC) · Supplement 14AP
1992-12-17Manufacturing (CMC) · Supplement 16AP
1991-06-13Labeling · Supplement 11AP
1988-04-21Labeling · Supplement 10AP
1987-04-27Manufacturing (CMC) · Supplement 7AP
1987-04-27Manufacturing (CMC) · Supplement 3AP
1980-02-04OriginalAP
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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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