Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 213978
Company: OYSTER POINT PHARMA
Company: OYSTER POINT PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TYRVAYA | VARENICLINE TARTRATE | EQ 0.03MG BASE/SPRAY | SPRAY;NASAL | 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 |
---|---|---|---|---|---|---|---|
10/15/2021 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213978s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213978Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/213978Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/02/2024 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213978s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213978Orig1s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/02/2024 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213978s005lbl.pdf | |
02/02/2024 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213978s005lbl.pdf | |
10/15/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213978s000lbl.pdf |