FDA Approval for VOQUENZA TRIPLE PAK issued to PHATHOM PHARMACEUTICALS, INC
$PHAT
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 215152
Company: PHATHOM PHARMACEUTICALS, INC
Company: PHATHOM PHARMACEUTICALS, INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VOQUENZA TRIPLE PAK | AMOXICILLIN; CLARITHROMYCIN, VONOPRAZAN | 500MG/500MG/20MG | CAPSULE, 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 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215152s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215152Orig1s000, 215153Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/03/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215152s000lbl.pdf |
VOQUENZA TRIPLE PAK
There are no Therapeutic Equivalents.