MedPath
FDA Approval

DEFERASIROX

November 15, 2023

Human Prescription Drug Label

Deferasirox(360 mg in 1 1)

Manufacturing Establishments (1)

APL HEALTHCARE LIMITED

Aurobindo Pharma Limited

650918514

Products (3)

DEFERASIROX

59651-412

ANDA214474

ANDA (C73584)

ORAL

November 15, 2023

Code: V8G4MOF2V9Class: ACTIBQuantity: 360 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

DEFERASIROX

59651-410

ANDA214474

ANDA (C73584)

ORAL

November 15, 2023

Code: V8G4MOF2V9Class: ACTIBQuantity: 90 mg in 1 1
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

DEFERASIROX

59651-411

ANDA214474

ANDA (C73584)

ORAL

November 15, 2023

Code: V8G4MOF2V9Class: ACTIBQuantity: 180 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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