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FDA NDA · NDA018388
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
NDA018388
TYPE
NDA
ORIGINAL APPROVAL
1980-12-19
LATEST ACTION
2014-05-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
LIDOCAINE HYDROCHLORIDE 400MG/100ML · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
LIDOCAINE HYDROCHLORIDE 800MG/100ML · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
LIDOCAINE HYDROCHLORIDE 200MG/100ML · INJECTABLE · INJECTION
Approval history
2014-05-09Manufacturing (CMC) · Supplement 86 · standardAP
2014-04-07Manufacturing (CMC) · Supplement 85 · standardAP
1999-08-26Labeling · Supplement 64 · standardAP
1999-08-26Labeling · Supplement 67 · standardAP
1998-11-05Manufacturing (CMC) · Supplement 66 · standardAP
1997-06-12Manufacturing (CMC) · Supplement 65 · standardAP
1997-03-18Manufacturing (CMC) · Supplement 63 · standardAP
1996-07-17Manufacturing (CMC) · Supplement 59 · standardAP
1996-07-09Manufacturing (CMC) · Supplement 62 · standardAP
1996-06-26Manufacturing (CMC) · Supplement 58 · standardAP
1996-02-02Manufacturing (CMC) · Supplement 61 · standardAP
1995-08-17Manufacturing (CMC) · Supplement 56 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 60 · standardAP
1993-11-03Labeling · Supplement 55 · standardAP
1992-05-01Manufacturing (CMC) · Supplement 48 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 53 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 52 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 54 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 49 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 50 · standardAP
1989-09-13Manufacturing (CMC) · Supplement 27 · standardAP
1986-12-15Manufacturing (CMC) · Supplement 41 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 45 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 44 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 40 · standardAP
1985-11-01Labeling · Supplement 38AP
1985-11-01Manufacturing (CMC) · Supplement 33 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 29 · standardAP
1985-10-26Manufacturing (CMC) · Supplement 36 · standardAP
1985-10-26Labeling · Supplement 39AP
1985-09-26Manufacturing (CMC) · Supplement 31 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 43 · standardAP
1985-05-10Manufacturing (CMC) · Supplement 42 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 37 · standardAP
1984-11-28Manufacturing (CMC) · Supplement 28 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 32 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 25 · standardAP
1984-10-10Labeling · Supplement 18AP
1984-10-10Manufacturing (CMC) · Supplement 17 · 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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