FDA Approval for XDEMVY issued to TARSUS PHARMACEUTICALS, INC.
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Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
New Drug Application (NDA): 217603
Company: TARSUS PHARMACEUTICALS, INC.
Company: TARSUS PHARMACEUTICALS, INC.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOLUTION/DROPS;OPHTHALMIC | Prescription | None | No | No | |||
| SOLUTION/DROPS;OPHTHALMIC | Prescription | None | No | No | |||
| XDEMVY | LOTILANER | 0.25% | SOLUTION/DROPS;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 07/24/2023 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217603Orig1s000ltr.pdf |