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FDA NDA · NDA020179

DEXTROSE

dextrose monohydrate

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA020179
TYPE
NDA
ORIGINAL APPROVAL
1992-12-07
LATEST ACTION
2022-12-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 5GM/100ML · INJECTABLE · INJECTION
DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 50MG/ML · INJECTABLE · INJECTION

Approval history

2022-12-07Manufacturing (CMC) · Supplement 26 — Letter ↗AP
2019-08-05Labeling · Supplement 12 · standard — Letter ↗AP
2019-08-05Labeling · Supplement 56 · standard — Label ↗AP
2003-11-20Labeling · Supplement 7AP
2001-05-04Manufacturing (CMC) · Supplement 5 · standardAP
1999-09-15Labeling · Supplement 3AP
1997-12-29Manufacturing (CMC) · Supplement 4 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 1 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 2 · standardAP
1992-12-07Type 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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