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FDA NDA · NDA019844
ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: B BRAUN
APPLICATION
NDA019844
TYPE
NDA
ORIGINAL APPROVAL
1993-06-10
LATEST ACTION
2004-05-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 97MG/100ML, SODIUM ACETATE 220MG/100ML, SODIUM CHLORIDE 140MG/100ML · INJECTABLE · INJECTION
Approval history
2004-05-14Labeling · Supplement 10AP
2002-07-01Manufacturing (CMC) · Supplement 9 · standardAP
2002-04-15Manufacturing (CMC) · Supplement 7 · standardAP
2000-12-07Manufacturing (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
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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