Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 216483
Company: UTILITY THERAP
Company: UTILITY THERAP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PIVYA | PIVMECILLINAM HYDROCHLORIDE | EQ 185MG BASE | 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 |
---|---|---|---|---|---|---|---|
04/24/2024 | ORIG-1 | Approval | Type 2 - New Active Ingredient | PRIORITY |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216483s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216483Orig1s000Corrected_ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/24/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216483s000lbl.pdf |