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 |
|---|---|---|---|---|---|---|---|
| XDEMVY | LOTILANER | 0.25% | SOLUTION/DROPS;OPHTHALMIC | Prescription | None | No | No |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/24/2023 | SUPPL-1 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217603Orig1s000ltr.pdf |