← FDA DRUG APPROVALS
FDA NDA · NDA018931
TRAVASOL
leucine, phenylalanine, lysine hydrochloride, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, tyrosine, serine
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA018931
TYPE
NDA
ORIGINAL APPROVAL
1984-08-23
LATEST ACTION
2020-09-23
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TRAVASOL 10% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 10% (10MG/100ML) · INJECTABLE · INJECTION
TRAVASOL 5.5% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 5.5% (5.5GM/100ML) · INJECTABLE · INJECTION
TRAVASOL 8.5% IN PLASTIC CONTAINERPrescription
AMINO ACIDS 8.5% (8.5GM/100ML) · INJECTABLE · INJECTION
Approval history
2016-01-15Manufacturing (CMC) · Supplement 50 · standardAP
2015-02-03Manufacturing (CMC) · Supplement 48 · standardAP
2014-09-15Manufacturing (CMC) · Supplement 44 · standardAP
2003-10-10Labeling · Supplement 35AP
2001-08-29Manufacturing (CMC) · Supplement 33 · standardAP
2001-02-28Labeling · Supplement 31AP
2000-04-21Manufacturing (CMC) · Supplement 32 · standardAP
2000-01-28Manufacturing (CMC) · Supplement 30 · standardAP
1999-07-30Manufacturing (CMC) · Supplement 29 · standardAP
1999-06-11Manufacturing (CMC) · Supplement 28 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 27 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 23 · standardAP
1994-08-05Manufacturing (CMC) · Supplement 26 · standardAP
1994-05-19Manufacturing (CMC) · Supplement 24 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 25 · standardAP
1993-05-12Manufacturing (CMC) · Supplement 16 · standardAP
1993-04-02Manufacturing (CMC) · Supplement 13 · standardAP
1993-04-02Manufacturing (CMC) · Supplement 12 · standardAP
1993-03-24Manufacturing (CMC) · Supplement 9 · standardAP
1992-12-11Labeling · Supplement 15AP
1992-09-14Manufacturing (CMC) · Supplement 17 · standardAP
1992-08-24Manufacturing (CMC) · Supplement 19 · standardAP
1992-02-27Manufacturing (CMC) · Supplement 21 · standardAP
1992-02-27Labeling · Supplement 20AP
1991-04-03Manufacturing (CMC) · Supplement 18 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 14 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 10 · standardAP
1990-05-04Manufacturing (CMC) · Supplement 11 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 8 · standardAP
1989-04-27Labeling · Supplement 2AP
1988-04-27Labeling · Supplement 7AP
1987-11-12Labeling · Supplement 4AP
1987-07-25Manufacturing (CMC) · Supplement 5 · standardAP
1985-09-20Manufacturing (CMC) · Supplement 1 · standardAP
1985-04-26Manufacturing (CMC) · Supplement 3 · standardAP
1984-08-23Type 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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