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FDA NDA · NDA019873

ISOLYTE P IN DEXTROSE

dextrose, sodium acetate, potassium chloride, magnesium chloride, and potassium phosphate, dibasic

Sponsor: B BRAUN

APPLICATION
NDA019873
TYPE
NDA
ORIGINAL APPROVAL
1993-06-10
LATEST ACTION
2004-05-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 31MG/100ML, POTASSIUM CHLORIDE 130MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 26MG/100ML, SODIUM ACETATE 320MG/100ML · INJECTABLE · INJECTION

Approval history

2004-05-11Labeling · Supplement 11AP
2002-07-01Manufacturing (CMC) · Supplement 10 · standardAP
2002-04-15Manufacturing (CMC) · Supplement 8 · standardAP
2000-12-07Manufacturing (CMC) · Supplement 7 · standardAP
2000-05-15Manufacturing (CMC) · Supplement 6 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 4 · standardAP
1995-10-26Manufacturing (CMC) · Supplement 3 · standardAP
1995-09-13Manufacturing (CMC) · Supplement 2 · standardAP
1994-06-01Labeling · Supplement 1AP
1993-06-10Type 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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