← FDA DRUG APPROVALS

FDA NDA · NDA020173

TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA020173
TYPE
NDA
ORIGINAL APPROVAL
1995-10-27
LATEST ACTION
2002-10-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 5.5%, MAGNESIUM CHLORIDE 102MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 522MG/100ML, SODIUM ACETATE 431MG/100ML, SODIUM CHLORIDE 224MG/100ML · INJECTABLE · INJECTION
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 8.5%, MAGNESIUM CHLORIDE 102MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 522MG/100ML, SODIUM ACETATE 594MG/100ML, SODIUM CHLORIDE 154MG/100ML · INJECTABLE · INJECTION

Approval history

2002-10-29Labeling · Supplement 12 · standardAP
2001-08-29Manufacturing (CMC) · Supplement 10 · standardAP
2001-02-28Labeling · Supplement 7 · standardAP
2000-06-09Manufacturing (CMC) · Supplement 9 · standardAP
2000-04-21Manufacturing (CMC) · Supplement 8 · standardAP
2000-01-28Manufacturing (CMC) · Supplement 6 · standardAP
1999-07-30Manufacturing (CMC) · Supplement 5 · standardAP
1999-06-11Manufacturing (CMC) · Supplement 4 · standardAP
1997-12-18Manufacturing (CMC) · Supplement 3 · standardAP
1997-10-17Manufacturing (CMC) · Supplement 2 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 1 · standardAP
1995-10-27Type 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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