APPLICATION
NDA017584
TYPE
NDA
ORIGINAL APPROVAL
1976-03-26
LATEST ACTION
1996-09-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
LIDOCAINE HYDROCHLORIDE 4% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
Approval history
1996-09-13Labeling · Supplement 28 · standardAP
1995-12-19Manufacturing (CMC) · Supplement 24 · standardAP
1995-12-19Manufacturing (CMC) · Supplement 25 · standardAP
1994-08-05Labeling · Supplement 19AP
1993-05-17Labeling · Supplement 27 · standardAP
1991-08-23Manufacturing (CMC) · Supplement 22 · standardAP
1987-04-07Manufacturing (CMC) · Supplement 21 · standardAP
1986-05-22Labeling · Supplement 16AP
1986-02-24Manufacturing (CMC) · Supplement 18 · standardAP
1986-02-14Labeling · Supplement 15AP
1985-04-30Manufacturing (CMC) · Supplement 14 · standardAP
1984-08-31Manufacturing (CMC) · Supplement 17 · standardAP
1982-12-08Manufacturing (CMC) · Supplement 12 · standardAP
1982-07-21Labeling · Supplement 13AP
1981-02-05Manufacturing (CMC) · Supplement 11 · standardAP
1980-01-09Labeling · Supplement 10AP
1979-07-10Manufacturing (CMC) · Supplement 9 · standardAP
1978-05-26Manufacturing (CMC) · Supplement 5 · standardAP
1978-05-26Labeling · Supplement 4AP
1977-12-01Manufacturing (CMC) · Supplement 8 · standardAP
1977-12-01Manufacturing (CMC) · Supplement 7 · standardAP
1977-07-12Manufacturing (CMC) · Supplement 6 · standardAP
1976-10-29Labeling · Supplement 3AP
1976-08-18Labeling · Supplement 2AP
1976-06-08Manufacturing (CMC) · Supplement 1 · standardAP
1976-03-26Type 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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