MedPath
FDA Approval

DEFERASIROX

December 12, 2022

HUMAN PRESCRIPTION DRUG LABEL

Deferasirox(360 mg in 1 1)

Manufacturing Establishments (1)

ALKALOIDA Chemical Company Zrt.

Sun Pharmaceutical Industries, Inc.

643611692

Products (3)

DEFERASIROX

57664-770

ANDA211641

ANDA (C73584)

ORAL

December 12, 2022

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958Class: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: V8G4MOF2V9Class: ACTIBQuantity: 360 mg in 1 1
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT

DEFERASIROX

57664-769

ANDA211641

ANDA (C73584)

ORAL

December 12, 2022

MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958Class: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
Code: V8G4MOF2V9Class: ACTIBQuantity: 180 mg in 1 1

DEFERASIROX

57664-768

ANDA211641

ANDA (C73584)

ORAL

December 12, 2022

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: V8G4MOF2V9Class: ACTIBQuantity: 90 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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