POSACONAZOLE
These highlights do not include all the information needed to use POSACONAZOLE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for POSACONAZOLE DELAYED-RELEASE TABLETS. POSACONAZOLE delayed-release tablets, for oral use Initial U.S. Approval: 2006
Approved
Approval ID
94a9b028-a2bc-4f41-884d-2d6c536881fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 5, 2022
Manufacturers
FDA
Lannett Company Inc.
DUNS: 002277481
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 Code0527-2133
Application NumberANDA212411
Product Classification
M
Marketing Category
C73584
G
Generic Name
Posaconazole
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2021
FDA Product Classification
INGREDIENTS (12)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POSACONAZOLEActive
Quantity: 100 mg in 1 1
Code: 6TK1G07BHZ
Classification: ACTIB
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)Inactive
Code: 36BGF0E889
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT