FDA Approval for VOQUEZNA DUAL PAK issued to PHATHOM PHARMACEUTICALS, INC
$PHAT
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 215153
Company: PHATHOM PHARMACEUTICALS, INC
Company: PHATHOM PHARMACEUTICALS, INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VOQUEZNA DUAL PAK | AMOXICILLIN; VONOPRAZAN | 500MG/20MG | CAPSULE, TABLET | Prescription | TBD | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 05/03/2022 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215152Orig1s000, 215153Orig1s000ltr.pdf |
VOQUEZNA DUAL PAK
There are no Therapeutic Equivalents.