APPLICATION
ANDA084048
TYPE
ANDA
ORIGINAL APPROVAL
1980-09-09
LATEST ACTION
1999-08-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
OCTOCAINEDiscontinued
EPINEPHRINE 0.02MG/ML, LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
OCTOCAINEDiscontinued
EPINEPHRINE 0.01MG/ML, LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
Approval history
1999-08-02Manufacturing (CMC) · Supplement 24AP
1998-12-10Manufacturing (CMC) · Supplement 23AP
1998-04-08Labeling · Supplement 22AP
1993-01-26Manufacturing (CMC) · Supplement 19AP
1992-01-14Labeling · Supplement 20AP
1992-01-14Labeling · Supplement 21AP
1990-06-29Manufacturing (CMC) · Supplement 16AP
1990-06-29Manufacturing (CMC) · Supplement 14AP
1990-06-29Labeling · Supplement 17AP
1990-06-29Manufacturing (CMC) · Supplement 15AP
1984-01-10Manufacturing (CMC) · Supplement 12AP
1983-04-12Manufacturing (CMC) · Supplement 10AP
1982-07-15Manufacturing (CMC) · Supplement 5AP
1980-09-09OriginalAP
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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