Registrants (1)
Zydus Pharmaceuticals USA Inc.
156861945
Manufacturing Establishments (1)
Zydus Lifesciences Limited
Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc.
863362789
Products (3)
deferasirox
70710-1277
ANDA211383
ANDA (C73584)
ORAL
July 24, 2023
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
DeferasiroxActive
Code: V8G4MOF2V9Class: ACTIBQuantity: 360 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
deferasirox
70710-1275
ANDA211383
ANDA (C73584)
ORAL
July 24, 2023
DeferasiroxActive
Code: V8G4MOF2V9Class: ACTIBQuantity: 90 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
deferasirox
70710-1276
ANDA211383
ANDA (C73584)
ORAL
July 24, 2023
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
DeferasiroxActive
Code: V8G4MOF2V9Class: ACTIBQuantity: 180 mg in 1 1
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT