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FDA Approval

TrophAmine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
B. Braun Medical Inc.
DUNS: 002397347
Effective Date
August 22, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Isoleucine(0.82 g in 100 mL)
Leucine(1.4 g in 100 mL)
Phenylalanine(0.48 g in 100 mL)
Lysine(1.2 g in 100 mL)
Methionine(0.34 g in 100 mL)
Threonine(0.42 g in 100 mL)
Tryptophan(0.2 g in 100 mL)
Valine(0.78 g in 100 mL)
Histidine(0.48 g in 100 mL)
Cysteine(0.024 g in 100 mL)
Tyrosine(0.044 g in 100 mL)
acetyl l-tyrosine(0.24 g in 100 mL)
Arginine(1.2 g in 100 mL)
Alanine(0.54 g in 100 mL)
Proline(0.68 g in 100 mL)
Serine(0.38 g in 100 mL)
Glycine(0.36 g in 100 mL)
Aspartic acid(0.32 g in 100 mL)
Glutamic acid(0.5 g in 100 mL)
Taurine(0.025 g in 100 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

TrophAmine

Product Details

NDC Product Code
0264-1933
Application Number
NDA019018
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
August 22, 2022
IsoleucineActive
Code: 04Y7590D77Class: ACTIBQuantity: 0.82 g in 100 mL
LeucineActive
Code: GMW67QNF9CClass: ACTIBQuantity: 1.4 g in 100 mL
PhenylalanineActive
Code: 47E5O17Y3RClass: ACTIBQuantity: 0.48 g in 100 mL
LysineActive
Code: TTL6G7LIWZClass: ACTIMQuantity: 1.2 g in 100 mL
MethionineActive
Code: AE28F7PNPLClass: ACTIBQuantity: 0.34 g in 100 mL
ThreonineActive
Code: 2ZD004190SClass: ACTIBQuantity: 0.42 g in 100 mL
TryptophanActive
Code: 8DUH1N11BXClass: ACTIBQuantity: 0.2 g in 100 mL
ValineActive
Code: HG18B9YRS7Class: ACTIBQuantity: 0.78 g in 100 mL
HistidineActive
Code: 4QD397987EClass: ACTIBQuantity: 0.48 g in 100 mL
CysteineActive
Code: ZT934N0X4WClass: ACTIMQuantity: 0.024 g in 100 mL
TyrosineActive
Code: 42HK56048UClass: ACTIBQuantity: 0.044 g in 100 mL
acetyl l-tyrosineActive
Code: DA8G610ZO5Class: ACTIBQuantity: 0.24 g in 100 mL
ArginineActive
Code: 94ZLA3W45FClass: ACTIBQuantity: 1.2 g in 100 mL
AlanineActive
Code: OF5P57N2ZXClass: ACTIBQuantity: 0.54 g in 100 mL
ProlineActive
Code: 9DLQ4CIU6VClass: ACTIBQuantity: 0.68 g in 100 mL
SerineActive
Code: 452VLY9402Class: ACTIBQuantity: 0.38 g in 100 mL
GlycineActive
Code: TE7660XO1CClass: ACTIBQuantity: 0.36 g in 100 mL
Aspartic acidActive
Code: 30KYC7MIAIClass: ACTIBQuantity: 0.32 g in 100 mL
Glutamic acidActive
Code: 3KX376GY7LClass: ACTIBQuantity: 0.5 g in 100 mL
TaurineActive
Code: 1EQV5MLY3DClass: ACTIBQuantity: 0.025 g in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
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