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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215151
Company: PHATHOM

Products on NDA 215151

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VOQUEZNA	VONOPRAZAN FUMARATE	EQ 10MG BASE	TABLET;ORAL	Prescription	None	Yes	No
VOQUEZNA	VONOPRAZAN FUMARATE	EQ 20MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215151

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/01/2023	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215151s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215151Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/215151Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/06/2025	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215151s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215151Orig1s009ltr.pdf
07/17/2024	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215151s006,218710s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218710Orig1s000,215151Orig1s006ltr.pdf

Labels for NDA 215151

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/06/2025	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215151s009lbl.pdf
07/17/2024	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215151s006,218710s000lbl.pdf
11/01/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215151s000lbl.pdf

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