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: |
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