FDA NDA · NDA019830

LIDOCAINE HYDROCHLORIDE AND DEXTROSE

lidocaine hydrochloride anhydrous and dextrose monohydrate

Sponsor: B BRAUN

APPLICATION

NDA019830

TYPE

NDA

ORIGINAL APPROVAL

1992-04-08

LATEST ACTION

2020-05-19

ROUTE

INTRAVENOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

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

2020-05-19Labeling · Supplement 27 · standard — Letter ↗AP

2017-01-13Manufacturing (CMC) · Supplement 20 · standardAP

2014-08-22Manufacturing (CMC) · Supplement 15 · standardAP

2013-02-01Labeling · Supplement 18 · unknown — Letter ↗AP

2004-06-24Labeling · Supplement 8 · standard — Letter ↗AP

2002-07-15Manufacturing (CMC) · Supplement 7 · standardAP

2002-03-04Manufacturing (CMC) · Supplement 5 · standardAP

2001-03-13Manufacturing (CMC) · Supplement 4 · standardAP

1998-07-20Manufacturing (CMC) · Supplement 3 · standardAP

1994-03-31Labeling · Supplement 2 · standardAP

1993-03-16Manufacturing (CMC) · Supplement 1 · standardAP

1992-04-08Type 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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