← FDA DRUG APPROVALS

FDA NDA · NDA216157

OXBRYTA

voxelotor

Sponsor: GLOBAL BLOOD THERAPS

APPLICATION
NDA216157
TYPE
NDA
ORIGINAL APPROVAL
2021-12-17
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION, TABLET
MARKETING STATUS
Discontinued

Products

OXBRYTA · ReferenceDiscontinued
VOXELOTOR 300MG · TABLET, FOR SUSPENSION · ORAL
OXBRYTADiscontinued
VOXELOTOR 500MG · TABLET · ORAL

Approval history

2023-08-18Labeling · Supplement 3 · standard — Label ↗AP
2021-12-17Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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