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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215153
Company: PHATHOM

Products on NDA 215153

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VOQUEZNA DUAL PAK	AMOXICILLIN; VONOPRAZAN FUMARATE	500MG;EQ 20MG BASE	CAPSULE, TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215153

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/2022	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215152s000,215153s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215152Orig1s000, 215153Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215152Orig1s000,215153Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2025	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215152s015,215153s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215152Orig1s015,215153Orig1s014ltr.pdf
10/31/2025	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215152s012,215153s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215152Orig1s012,215153Orig1s012ltr.pdf
05/01/2024	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215152s007,215153s007lbl.pdf
08/16/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215152s004,215153s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215152Orig1s004;215153Orig1s004ltr.pdf
07/31/2024	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215152s003,215153s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215152Orig1s003, 215153Orig1s003ltr.pdf

Labels for NDA 215153

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2025	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215152s012,215153s012lbl.pdf
06/12/2025	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215152s015,215153s014lbl.pdf
07/31/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215152s003,215153s003lbl.pdf
05/01/2024	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215152s007,215153s007lbl.pdf
08/16/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215152s004,215153s004lbl.pdf
05/03/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215152s000,215153s000lbl.pdf

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