Application 018931

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAVASOL 5.5% IN PLASTIC CONTAINERAMINO ACIDSINJECTABLE;INJECTION5.5% (5.5GM/100ML)NoNo
002TRAVASOL 8.5% IN PLASTIC CONTAINERAMINO ACIDSINJECTABLE;INJECTION8.5% (8.5GM/100ML)NoNo
003TRAVASOL 10% IN PLASTIC CONTAINERAMINO ACIDSINJECTABLE;INJECTION10% (10MG/100ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0644TravasolLeucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, SerineBaxter Healthcare CorporationNDACurrent
0338-0644TravasolLeucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, SerineBaxter Healthcare CorporationNDACurrent
0338-0644TravasolLeucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, SerineBaxter Healthcare CorporationNDACurrent
0338-0644TravasolLeucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, SerineBaxter Healthcare CorporationNDACurrent
0338-0644TravasolLeucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, SerineBaxter Healthcare CorporationNDACurrent
0338-0644TravasolLeucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, SerineBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64714SUPPL2020-09-29
64662SUPPL2020-09-24
50447SUPPL2017-11-17
50442SUPPL2017-11-17