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FDA NDA · NDA019520
TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA019520
TYPE
NDA
ORIGINAL APPROVAL
1988-09-23
LATEST ACTION
2001-08-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 4.25%, DEXTROSE 25GM/100ML · INJECTABLE · INJECTION
TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 2.75%, DEXTROSE 10GM/100ML · INJECTABLE · INJECTION
TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 4.25%, DEXTROSE 20GM/100ML · INJECTABLE · INJECTION
TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 4.25%, DEXTROSE 10GM/100ML · INJECTABLE · INJECTION
TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 2.75%, DEXTROSE 25GM/100ML · INJECTABLE · INJECTION
TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 2.75%, DEXTROSE 15GM/100ML · INJECTABLE · INJECTION
TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 2.75%, DEXTROSE 5GM/100ML · INJECTABLE · INJECTION
TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 4.25%, DEXTROSE 15GM/100ML · INJECTABLE · INJECTION
TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 4.25%, DEXTROSE 5GM/100ML · INJECTABLE · INJECTION
TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINERDiscontinued
AMINO ACIDS 2.75%, DEXTROSE 20GM/100ML · INJECTABLE · INJECTION
Approval history
2001-08-14Manufacturing (CMC) · Supplement 21 · standardAP
2000-03-24Manufacturing (CMC) · Supplement 20 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 19 · standardAP
1999-03-31Manufacturing (CMC) · Supplement 17 · standardAP
1997-11-18Labeling · Supplement 16 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 15 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 12 · standardAP
1994-05-19Manufacturing (CMC) · Supplement 13 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 14 · standardAP
1993-05-05Manufacturing (CMC) · Supplement 5 · standardAP
1992-09-14Manufacturing (CMC) · Supplement 6 · standardAP
1992-08-24Manufacturing (CMC) · Supplement 7 · standardAP
1992-02-27Labeling · Supplement 8AP
1992-02-27Manufacturing (CMC) · Supplement 9 · standardAP
1991-12-30Manufacturing (CMC) · Supplement 11 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 4 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 2 · standardAP
1990-05-04Manufacturing (CMC) · Supplement 3 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 1 · standardAP
1988-09-23Type 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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