Posaconazole
These highlights do not include all the information needed to use POSACONAZOLE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DELAYED-RELEASE TABLETS . delayed-release tablets, for oral use Initial U.S. Approval: 2006
Approved
Approval ID
4d14ceab-196e-4dc3-8b21-5c4629ada161
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2025
Manufacturers
FDA
A2A Integrated Pharmaceuticals
DUNS: 117064671
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 Code73141-023
Application NumberANDA216488
Product Classification
M
Marketing Category
C73584
G
Generic Name
Posaconazole
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2025
FDA Product Classification
INGREDIENTS (15)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)Inactive
Code: 36BGF0E889
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)Inactive
Code: 24P2YXD2PW
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POSACONAZOLEActive
Quantity: 100 mg in 1 1
Code: 6TK1G07BHZ
Classification: ACTIB