| NDC Code: |
0264-1915 |
| Proprietary Name: |
ProcalAmine |
| Suffix: |
|
| Non-Proprietary Name: |
GLYCERIN, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, GLYCINE, ARGININE, HISTIDINE, PROLINE, SERINE, CYSTEINE, SODIUM ACETATE, MAGNESIUM ACETATE, CALCIUM ACETATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, PHOSPHORIC ACID, and POTASSIUM METABISULFITE |
| Dosage Form: |
INJECTION |
| Method: |
INTRAVENOUS |
| Original Marketing Date: |
06-05-1982 |
| Category Name: |
NDA |
| Application Number: |
NDA018582 |
| Labeler: |
B. BRAUN MEDICAL INC. |
| Substance Name: |
ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE |
| Active Numerator Strength: |
.21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2 |
| Active Ingredient Unit: |
g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL |
| Pharm Classes: |
Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Amino Acid [EPC],Amino Acids [Chemical/Ingredient] |
| DEA Schedule: |
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