POSACONAZOLE
These highlights do not include all the information needed to use POSACONAZOLE INJECTION safely and effectively. See full prescribing information for POSACONAZOLE INJECTION. POSACONAZOLE injection, for intravenous use Initial U.S. Approval: 2006
Approved
Approval ID
2e88e379-b712-4dec-97a2-c90ef3638372
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
POSACONAZOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-388
Application NumberANDA214842
Product Classification
M
Marketing Category
C73584
G
Generic Name
POSACONAZOLE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 20, 2022
FDA Product Classification
INGREDIENTS (6)
POSACONAZOLEActive
Quantity: 18 mg in 1 mL
Code: 6TK1G07BHZ
Classification: ACTIB
BETADEX SULFOBUTYL ETHER SODIUMInactive
Code: 2PP9364507
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT