← FDA DRUG APPROVALS
FDA NDA · NDA020147
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA020147
TYPE
NDA
ORIGINAL APPROVAL
1995-10-23
LATEST ACTION
2001-08-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 4.25%, DEXTROSE 15GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 297MG/100ML, SODIUM CHLORIDE 77MG/100ML · INJECTABLE · INJECTION
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 4.25%, DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 297MG/100ML, SODIUM CHLORIDE 77MG/100ML · INJECTABLE · INJECTION
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 2.75%, DEXTROSE 20GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 216MG/100ML, SODIUM CHLORIDE 112MG/100ML · INJECTABLE · INJECTION
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 4.25%, DEXTROSE 25GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 297MG/100ML, SODIUM CHLORIDE 77MG/100ML · INJECTABLE · INJECTION
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 2.75%, DEXTROSE 10GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 216MG/100ML, SODIUM CHLORIDE 112MG/100ML · INJECTABLE · INJECTION
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 4.25%, DEXTROSE 20GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 297MG/100ML, SODIUM CHLORIDE 77MG/100ML · INJECTABLE · INJECTION
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 4.25%, DEXTROSE 10GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 297MG/100ML, SODIUM CHLORIDE 77MG/100ML · INJECTABLE · INJECTION
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 2.75%, DEXTROSE 25GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 216MG/100ML, SODIUM CHLORIDE 112MG/100ML · INJECTABLE · INJECTION
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 2.75%, DEXTROSE 15GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 216MG/100ML, SODIUM CHLORIDE 112MG/100ML · INJECTABLE · INJECTION
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 2.75%, DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 51MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML, SODIUM ACETATE 216MG/100ML, SODIUM CHLORIDE 112MG/100ML · INJECTABLE · INJECTION
Approval history
2001-08-14Manufacturing (CMC) · Supplement 9 · standardAP
2000-03-24Manufacturing (CMC) · Supplement 8 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 7 · standardAP
1999-03-31Manufacturing (CMC) · Supplement 4 · standardAP
1997-11-06Manufacturing (CMC) · Supplement 3 · standardAP
1997-10-09Labeling · Supplement 2 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 1 · standardAP
1995-10-23Type 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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