Posaconazole

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

Company

DUNS: 092733690

Effective Date

June 2, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Posaconazole(18 mg in 1 mL)

Products1

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

NDC Product Code

42023-195

Application Number

ANDA208768

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

June 2, 2022

Ingredients

Code: 6TK1G07BHZClass: ACTIBQuantity: 18 mg in 1 mL

SULFOBUTYLETHER .BETA.-CYCLODEXTRINInactive

Code: 2PP9364507Class: IACTQuantity: 400 mg in 1 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACTQuantity: 0.2 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT