Product NDC: | 0409-0468 |
Proprietary Name: | Novamine |
Non Proprietary Name: | LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE |
Active Ingredient(s): | 2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960 g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL & nbsp; LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION, CONCENTRATE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0409-0468 |
Labeler Name: | Hospira, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA017957 |
Marketing Category: | NDA |
Start Marketing Date: | 20111122 |
Package NDC: | 0409-0468-05 |
Package Description: | 1 BOTTLE in 1 CARTON (0409-0468-05) > 500 mL in 1 BOTTLE |
NDC Code | 0409-0468-05 |
Proprietary Name | Novamine |
Package Description | 1 BOTTLE in 1 CARTON (0409-0468-05) > 500 mL in 1 BOTTLE |
Product NDC | 0409-0468 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE |
Dosage Form Name | INJECTION, SOLUTION, CONCENTRATE |
Route Name | INTRAVENOUS |
Start Marketing Date | 20111122 |
Marketing Category Name | NDA |
Labeler Name | Hospira, Inc. |
Substance Name | ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
Strength Number | 2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960 |
Strength Unit | g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL |
Pharmaceutical Classes | Amino Acid [EPC],Amino Acids [Chemical/Ingredient] |