TrophAmine
TrophAmine (Amino Acid Injection)
Approved
Approval ID
cb6d23ff-3ec5-445a-acbe-f88fd57949bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2022
Manufacturers
FDA
B. Braun Medical Inc.
DUNS: 002397347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0264-1933
Application NumberNDA019018
Product Classification
M
Marketing Category
C73594
G
Generic Name
ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 22, 2022
FDA Product Classification
INGREDIENTS (22)
ISOLEUCINEActive
Quantity: 0.82 g in 100 mL
Code: 04Y7590D77
Classification: ACTIB
LEUCINEActive
Quantity: 1.4 g in 100 mL
Code: GMW67QNF9C
Classification: ACTIB
PHENYLALANINEActive
Quantity: 0.48 g in 100 mL
Code: 47E5O17Y3R
Classification: ACTIB
LYSINE ACETATEActive
Quantity: 1.2 g in 100 mL
Code: TTL6G7LIWZ
Classification: ACTIM
METHIONINEActive
Quantity: 0.34 g in 100 mL
Code: AE28F7PNPL
Classification: ACTIB
THREONINEActive
Quantity: 0.42 g in 100 mL
Code: 2ZD004190S
Classification: ACTIB
TRYPTOPHANActive
Quantity: 0.2 g in 100 mL
Code: 8DUH1N11BX
Classification: ACTIB
VALINEActive
Quantity: 0.78 g in 100 mL
Code: HG18B9YRS7
Classification: ACTIB
HISTIDINEActive
Quantity: 0.48 g in 100 mL
Code: 4QD397987E
Classification: ACTIB
CYSTEINE HYDROCHLORIDEActive
Quantity: 0.024 g in 100 mL
Code: ZT934N0X4W
Classification: ACTIM
TYROSINEActive
Quantity: 0.044 g in 100 mL
Code: 42HK56048U
Classification: ACTIB
ACETYL L-TYROSINEActive
Quantity: 0.24 g in 100 mL
Code: DA8G610ZO5
Classification: ACTIB
ARGININEActive
Quantity: 1.2 g in 100 mL
Code: 94ZLA3W45F
Classification: ACTIB
ALANINEActive
Quantity: 0.54 g in 100 mL
Code: OF5P57N2ZX
Classification: ACTIB
PROLINEActive
Quantity: 0.68 g in 100 mL
Code: 9DLQ4CIU6V
Classification: ACTIB
SERINEActive
Quantity: 0.38 g in 100 mL
Code: 452VLY9402
Classification: ACTIB
GLYCINEActive
Quantity: 0.36 g in 100 mL
Code: TE7660XO1C
Classification: ACTIB
ASPARTIC ACIDActive
Quantity: 0.32 g in 100 mL
Code: 30KYC7MIAI
Classification: ACTIB
GLUTAMIC ACIDActive
Quantity: 0.5 g in 100 mL
Code: 3KX376GY7L
Classification: ACTIB
TAURINEActive
Quantity: 0.025 g in 100 mL
Code: 1EQV5MLY3D
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT