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Premasol - sulfite-free (Amino Acid) - LEUCINE, LYSINE ACETATE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPA

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Field Value
NDC Code: 0338-1130
Proprietary Name: Premasol - sulfite-free (Amino Acid)
Suffix:
Non-Proprietary Name: LEUCINE, LYSINE ACETATE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPA
Dosage Form: INJECTION
Method: INTRAVENOUS
Original Marketing Date: 08-05-2007
Category Name: ANDA
Application Number: ANDA075880
Labeler: BAXTER HEALTHCARE CORPORATION
Substance Name: ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; N-ACETYL-TYROSINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
Active Numerator Strength: 5.4; 12; 3.2; .23; 5.25; 3.6; 4.8; 8.2; 14; 11.57; 3.4; 2.4; 4.8; 6.8; 3.8; .25; 4.2; 2; .44; 7.8
Active Ingredient Unit: g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL
Pharm Classes: Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Carbamoyl Phosphate Synthetase 1 Activator [EPC],Carbamoyl Phosphate Synthetase 1 Activators [MoA]
DEA Schedule: