FDA Approval for MYDCOMBI issued to EYENOVIA INC.
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 215352
Company: EYENOVIA INC.
Company: EYENOVIA INC.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYDCOMBI | TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE | 1%/2.5% | SPRAY;OPTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 05/05/2023 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215352Orig1s000ltr.pdf |