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FDA NDA · NDA019626

DEXTROSE

Sponsor: B BRAUN

APPLICATION
NDA019626
TYPE
NDA
ORIGINAL APPROVAL
1988-02-02
LATEST ACTION
2015-11-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

DEXTROSE 70% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 70GM/100ML · INJECTABLE · INJECTION
DEXTROSE 7.7% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 7.7GM/100ML · INJECTABLE · INJECTION
DEXTROSE 2.5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 2.5GM/100ML · INJECTABLE · INJECTION
DEXTROSE 10% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 10GM/100ML · INJECTABLE · INJECTION
DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 5GM/100ML · INJECTABLE · INJECTION

Approval history

2015-11-20Manufacturing (CMC) · Supplement 31 · standardAP
2015-02-18Manufacturing (CMC) · Supplement 30 · standard — Label ↗AP
2014-08-22Manufacturing (CMC) · Supplement 27 · standardAP
2004-02-13Manufacturing (CMC) · Supplement 19 · standard — Letter ↗AP
2002-07-23Manufacturing (CMC) · Supplement 18 · standardAP
2002-03-08Manufacturing (CMC) · Supplement 16 · standardAP
2001-03-12Manufacturing (CMC) · Supplement 15 · standardAP
2000-04-11Manufacturing (CMC) · Supplement 14 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 13 · standardAP
1993-07-21Manufacturing (CMC) · Supplement 10 · standardAP
1993-06-01Manufacturing (CMC) · Supplement 12 · standardAP
1993-04-26Manufacturing (CMC) · Supplement 11 · standardAP
1991-08-29Manufacturing (CMC) · Supplement 8 · standardAP
1990-09-18Manufacturing (CMC) · Supplement 7 · standardAP
1990-04-13Manufacturing (CMC) · Supplement 6 · standardAP
1989-11-21Manufacturing (CMC) · Supplement 3 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 5 · standardAP
1989-05-05Manufacturing (CMC) · Supplement 4 · standardAP
1988-12-21Manufacturing (CMC) · Supplement 2 · standardAP
1988-03-16Labeling · Supplement 1AP
1988-02-02Type 5 - New Formulation or New Manufacturer · Original · 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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