FDA Approval for VOQUEZNA issued to PHATHOM PHARMACEUTICALS INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 218710
Company: PHATHOM PHARMACEUTICALS INC
Company: PHATHOM PHARMACEUTICALS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VOQUEZNA | VONOPRAZAN FUMARATE | EQ 10MG BASE | TABLET; ORAL | Prescription | None | No | No |
| VOQUEZNA | VONOPRAZAN FUMARATE | EQ 20MG BASE | TABLET; ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/17/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218710Orig1s000,215151Orig1s006ltr.pdf |