Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
i3 Pharmaceuticals, LLC
080127275
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
i3 Pharmaceuticals, LLC
A2A Integrated Pharmaceuticals
i3 Pharmaceuticals, LLC
080127275
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
73141-023Application Number
ANDA216488Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 28, 2025CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PWClass: IACT
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)Inactive
Code: 36BGF0E889Class: IACT
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)Inactive
Code: 24P2YXD2PWClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
PosaconazoleActive
Code: 6TK1G07BHZClass: ACTIBQuantity: 100 mg in 1 1