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FDA ANDA · ANDA080406

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Sponsor: WEST-WARD PHARMS INT

APPLICATION
ANDA080406
TYPE
ANDA
ORIGINAL APPROVAL
1972-03-13
LATEST ACTION
1998-11-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE · ReferenceDiscontinued
EPINEPHRINE 0.01MG/ML, LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEDiscontinued
EPINEPHRINE 0.01MG/ML, LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION

Approval history

1998-11-23Manufacturing (CMC) · Supplement 43AP
1996-09-27Manufacturing (CMC) · Supplement 42AP
1996-03-06Manufacturing (CMC) · Supplement 41AP
1994-07-18Manufacturing (CMC) · Supplement 40AP
1991-07-31Manufacturing (CMC) · Supplement 39AP
1990-09-13Labeling · Supplement 38AP
1990-05-24Labeling · Supplement 37AP
1989-09-27Labeling · Supplement 33AP
1989-04-06Manufacturing (CMC) · Supplement 35AP
1989-04-06Manufacturing (CMC) · Supplement 36AP
1988-11-23Manufacturing (CMC) · Supplement 9AP
1988-11-16Labeling · Supplement 44AP
1988-11-16Labeling · Supplement 34AP
1986-11-03Manufacturing (CMC) · Supplement 32AP
1983-05-31Manufacturing (CMC) · Supplement 27AP
1982-09-29Manufacturing (CMC) · Supplement 28AP
1972-03-13OriginalAP
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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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