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FDA NDA · NDA018461

LIDOCAINE HYDROCHLORIDE AND DEXTROSE

lidocaine hydrochloride

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA018461
TYPE
NDA
ORIGINAL APPROVAL
1981-04-22
LATEST ACTION
2017-02-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINERPrescription
LIDOCAINE HYDROCHLORIDE 800MG/100ML · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERPrescription
LIDOCAINE HYDROCHLORIDE 200MG/100ML · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERPrescription
LIDOCAINE HYDROCHLORIDE 400MG/100ML · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
LIDOCAINE HYDROCHLORIDE 100MG/100ML · INJECTABLE · INJECTION

Approval history

2017-02-07Labeling · Supplement 58 · standard — Label ↗AP
2015-04-07Manufacturing (CMC) · Supplement 57 · standardAP
2012-03-05Labeling · Supplement 56 · unknown — Letter ↗AP
2012-02-27Labeling · Supplement 55 · standard — Letter ↗AP
2003-12-11Labeling · Supplement 52 · standard — Letter ↗AP
2002-01-23Labeling · Supplement 50 · standard — Review ↗AP
1999-11-23Manufacturing (CMC) · Supplement 48 · standardAP
1999-06-03Manufacturing (CMC) · Supplement 47 · standardAP
1998-09-18Labeling · Supplement 46 · standardAP
1994-09-29Manufacturing (CMC) · Supplement 45 · standardAP
1994-03-16Manufacturing (CMC) · Supplement 44 · standardAP
1993-01-08Labeling · Supplement 43 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 40 · standardAP
1991-04-03Manufacturing (CMC) · Supplement 41 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 38 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 37 · standardAP
1990-05-24Manufacturing (CMC) · Supplement 39 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 36 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 35 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 33 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 32 · standardAP
1986-09-04Labeling · Supplement 23AP
1986-06-19Labeling · Supplement 31AP
1986-02-27Manufacturing (CMC) · Supplement 28 · standardAP
1985-09-13Labeling · Supplement 26AP
1985-06-13Manufacturing (CMC) · Supplement 25 · standardAP
1985-06-11Manufacturing (CMC) · Supplement 20 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 27 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 17 · standardAP
1984-10-23Manufacturing (CMC) · Supplement 24 · standardAP
1984-04-30Labeling · Supplement 21AP
1984-03-16Manufacturing (CMC) · Supplement 14 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 22 · standardAP
1983-03-14Manufacturing (CMC) · Supplement 18 · standardAP
1982-06-03Manufacturing (CMC) · Supplement 7 · standardAP
1982-05-25Labeling · Supplement 12AP
1982-04-16Manufacturing (CMC) · Supplement 4 · standardAP
1982-02-22Labeling · Supplement 9AP
1982-02-22Manufacturing (CMC) · Supplement 8 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 3 · standardAP
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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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