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FDA NDA · NDA019711

ISOLYTE S

sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride

Sponsor: B BRAUN

APPLICATION
NDA019711
TYPE
NDA
ORIGINAL APPROVAL
1989-09-29
LATEST ACTION
2004-02-19
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ISOLYTE S IN PLASTIC CONTAINERPrescription
MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM ACETATE 370MG/100ML, SODIUM CHLORIDE 530MG/100ML, SODIUM GLUCONATE 500MG/100ML · INJECTABLE · INJECTION

Approval history

2004-02-19Labeling · Supplement 19AP
2002-07-01Manufacturing (CMC) · Supplement 18 · standardAP
2002-04-15Manufacturing (CMC) · Supplement 16 · standardAP
2000-12-07Manufacturing (CMC) · Supplement 15 · standardAP
2000-06-12Manufacturing (CMC) · Supplement 12 · standardAP
2000-05-15Manufacturing (CMC) · Supplement 14 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 11 · standardAP
1995-10-26Manufacturing (CMC) · Supplement 10 · standardAP
1995-09-13Manufacturing (CMC) · Supplement 9 · standardAP
1995-04-04Manufacturing (CMC) · Supplement 8 · standardAP
1993-11-12Manufacturing (CMC) · Supplement 3 · standardAP
1993-07-21Manufacturing (CMC) · Supplement 6 · standardAP
1992-12-29Manufacturing (CMC) · Supplement 5 · standardAP
1990-09-21Manufacturing (CMC) · Supplement 2 · standardAP
1990-09-18Manufacturing (CMC) · Supplement 1 · standardAP
1989-09-29Type 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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