Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NOXAFIL
Product Details
NDC Product Code
0085-1328Application Number
NDA022003Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 20, 2023PosaconazoleActive
Code: 6TK1G07BHZClass: ACTIBQuantity: 40 mg in 1 mL
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
sodium benzoateInactive
Code: OJ245FE5EUClass: IACT
trisodium citrate dihydrateInactive
Code: B22547B95KClass: IACT
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACT
glycerinInactive
Code: PDC6A3C0OXClass: IACT
xanthan gumInactive
Code: TTV12P4NEEClass: IACT
anhydrous dextroseInactive
Code: 5SL0G7R0OKClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
NOXAFIL
Product Details
NDC Product Code
0085-4324Application Number
NDA205053Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 20, 2023HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473WClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
PosaconazoleActive
Code: 6TK1G07BHZClass: ACTIBQuantity: 100 mg in 1 1
NOXAFIL
Product Details
NDC Product Code
0085-2224Application Number
NDA214770Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 20, 2023PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZClass: IACT
PosaconazoleActive
Code: 6TK1G07BHZClass: ACTIBQuantity: 300 mg in 1 1
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473WClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311Class: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2Class: IACT
CALCIUM SULFATE, UNSPECIFIED FORMInactive
Code: WAT0DDB505Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
NOXAFIL
Product Details
NDC Product Code
0085-4331Application Number
NDA205596Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
October 20, 2023BETADEX SULFOBUTYL ETHER SODIUMInactive
Code: 2PP9364507Class: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
PosaconazoleActive
Code: 6TK1G07BHZClass: ACTIBQuantity: 18 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT