Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Eugia Pharma Specialities Limited
Eugia US LLC
650498244
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
POSACONAZOLE
Product Details
NDC Product Code
55150-388Application Number
ANDA214842Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
April 20, 2022PosaconazoleActive
Code: 6TK1G07BHZClass: ACTIBQuantity: 18 mg in 1 mL
BETADEX SULFOBUTYL ETHER SODIUMInactive
Code: 2PP9364507Class: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT