Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
ATLANTIC BIOLOGICALS CORP.
ATLANTIC BIOLOGICALS CORP.
047437707
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
17856-2133Application Number
ANDA212411Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 1, 2022HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)Inactive
Code: 36BGF0E889Class: IACT
PosaconazoleActive
Code: 6TK1G07BHZClass: ACTIBQuantity: 100 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT