Ethamolin
Ethamolin® (Ethanolamine Oleate) Injection, 5%. For Local Intravenous Use Only Rx only
Approved
Approval ID
a9c1d8c5-443e-400e-a42c-16a25fb47231
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
QOL Medical, LLC.
DUNS: 140026258
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ethanolamine Oleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67871-479
Application NumberNDA019357
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ethanolamine Oleate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (3)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
ETHANOLAMINE OLEATEActive
Quantity: 50 mg in 1 mL
Code: U4RY8MRX7C
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT