OXBRYTA

These highlights do not include all the information needed to use OXBRYTA safely and effectively. See full prescribing information for OXBRYTA. OXBRYTA (voxelotor) tablets, for oral use OXBRYTA (voxelotor) tablets for oral suspension Initial U.S. Approval: 2019

Approved

Approval ID

3c557fac-29ec-483f-b691-8a935d4decc3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 26, 2023

Manufacturers

FDA

Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.

DUNS: 028636495

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Voxelotor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72786-111

Application NumberNDA216157

Product Classification

Marketing Category

C73594

Generic Name

Voxelotor

Product Specifications

Route of AdministrationORAL

Effective DateAugust 21, 2023

FDA Product Classification

INGREDIENTS (9)

VoxelotorActive

Quantity: 300 mg in 1 1

Code: 3ZO554A4Q8

Classification: ACTIB

Microcrystalline CelluloseInactive

Code: OP1R32D61U

Classification: IACT

Croscarmellose SodiumInactive

Code: M28OL1HH48

Classification: IACT

SucraloseInactive

Code: 96K6UQ3ZD4

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

AcaciaInactive

Code: 5C5403N26O

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

Voxelotor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72786-101

Application NumberNDA213137

Product Classification

Marketing Category

C73594

Generic Name

Voxelotor

Product Specifications

Route of AdministrationORAL

Effective DateAugust 21, 2023

FDA Product Classification

INGREDIENTS (11)

Microcrystalline CelluloseInactive

Code: OP1R32D61U

Classification: IACT

Croscarmellose SodiumInactive

Code: M28OL1HH48

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

Polyethylene glycol 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

Titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

VoxelotorActive

Quantity: 500 mg in 1 1

Code: 3ZO554A4Q8

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

Voxelotor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72786-102

Application NumberNDA213137

Product Classification

Marketing Category

C73594

Generic Name

Voxelotor

Product Specifications

Route of AdministrationORAL

Effective DateAugust 21, 2023

FDA Product Classification

INGREDIENTS (12)

Croscarmellose SodiumInactive

Code: M28OL1HH48

Classification: IACT

Polyethylene glycol 3350Inactive

Code: G2M7P15E5P

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

VoxelotorActive

Quantity: 300 mg in 1 1

Code: 3ZO554A4Q8

Classification: ACTIB

Microcrystalline CelluloseInactive

Code: OP1R32D61U

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

Titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

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OXBRYTA

Products 3

Voxelotor

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (9)

Voxelotor

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

Voxelotor

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

MedPath

Product

Company

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