Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216157
Company: GLOBAL BLOOD THERAPS

Products on NDA 216157

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXBRYTA	VOXELOTOR	300MG	TABLET, FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes
OXBRYTA	VOXELOTOR	500MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216157

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2021	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/216157s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/216157Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/216157Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213137s012,216157s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213137Orig1s012,216157Orig1s003ltr.pdf

Labels for NDA 216157

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213137s012,216157s003lbl.pdf
08/18/2023	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213137s012,216157s003lbl.pdf
12/17/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/216157s000lbl.pdf