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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208712
Company: SOBI

Products on NDA 208712

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VONJO	PACRITINIB CITRATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208712

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2022	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208712s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208712Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/208712Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2026	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208712s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208712Orig1s007ltr.pdf
08/22/2025	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208712s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208712Orig1s006ltr.pdf
10/01/2025	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208712s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208712Orig1s004ltr.pdf
11/12/2024	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208712s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208712Orig1s003ltr.pdf
08/15/2023	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208712s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208712Orig1s001ltr.pdf

Labels for NDA 208712

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2026	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208712s007lbl.pdf
10/01/2025	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208712s004lbl.pdf
08/22/2025	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208712s006lbl.pdf
11/12/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208712s003lbl.pdf
08/15/2023	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208712s001lbl.pdf
02/28/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208712s000lbl.pdf

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