FDA Approval for TYRVAYA issued to OYSTER POINT PHARMA INC
$OYST
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 213978
Company: OYSTER POINT PHARMA INC
Company: OYSTER POINT PHARMA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TYRVAYA | VARENICLINE | 0.6MG/ML | SPRAY; NASAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 10/15/2021 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |