APPLICATION
NDA010496
TYPE
NDA
ORIGINAL APPROVAL
1958-03-11
LATEST ACTION
1999-03-12
ROUTE
SPINAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
XYLOCAINE 5% W/ GLUCOSE 7.5%Discontinued
LIDOCAINE HYDROCHLORIDE 5% · INJECTABLE · SPINAL
Approval history
1999-03-12Labeling · Supplement 19 · standardAP
1995-04-06Labeling · Supplement 18 · standardAP
1995-03-08Manufacturing (CMC) · Supplement 17 · standardAP
1993-02-18Manufacturing (CMC) · Supplement 16 · standardAP
1988-05-18Labeling · Supplement 14 · standardAP
1987-09-16Manufacturing (CMC) · Supplement 13 · standardAP
1985-02-21Labeling · Supplement 10 · standardAP
1982-07-07Labeling · Supplement 9 · standardAP
1982-07-07Manufacturing (CMC) · Supplement 8 · standardAP
1982-06-28Manufacturing (CMC) · Supplement 12 · standardAP
1982-03-25Manufacturing (CMC) · Supplement 11 · standardAP
1979-08-29Labeling · Supplement 7 · standardAP
1978-05-15Manufacturing (CMC) · Supplement 6 · standardAP
1958-03-11Type 4 - New Combination · 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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