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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215152
Company: PHATHOM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VOQUEZNA TRIPLE PAK AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE 500MG;500MG;EQ 20MG BASE CAPSULE, TABLET, TABLET;ORAL Prescription None Yes Yes
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 1 - New Molecular Entity and Type 4 - New Combination 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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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