APPLICATION
NDA017549
TYPE
NDA
ORIGINAL APPROVAL
1975-03-28
LATEST ACTION
2002-10-31
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LIDOPENDiscontinued
LIDOCAINE HYDROCHLORIDE 10% · INJECTABLE · INJECTION
Approval history
2002-10-31Manufacturing (CMC) · Supplement 20 · standardAP
2000-10-20Manufacturing (CMC) · Supplement 19 · standardAP
1999-12-08Manufacturing (CMC) · Supplement 18 · standardAP
1998-07-21Manufacturing (CMC) · Supplement 17 · standardAP
1997-04-18Manufacturing (CMC) · Supplement 16 · standardAP
1997-01-09Manufacturing (CMC) · Supplement 15 · standardAP
1996-06-06Manufacturing (CMC) · Supplement 14 · standardAP
1993-05-10Manufacturing (CMC) · Supplement 13 · standardAP
1988-12-23Manufacturing (CMC) · Supplement 12 · standardAP
1986-12-10Labeling · Supplement 11AP
1984-04-16Labeling · Supplement 8AP
1978-01-11Labeling · Supplement 7AP
1977-03-17Labeling · Supplement 4AP
1976-10-18Efficacy · Supplement 3AP
1975-12-04Manufacturing (CMC) · Supplement 2 · standardAP
1975-09-24Labeling · Supplement 1AP
1975-03-28Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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