Application 213978
- Type
- NDA
- Sponsor
- OYSTER POINT PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TYRVAYA | VARENICLINE TARTRATE | SOLUTION;NASAL | EQ 0.03MG BASE/SPRAY | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73521-030 | Tyrvaya | varenicline | Oyster Point Pharma | NDA | Current |
| 73521-030 | Tyrvaya | varenicline | Oyster Point Pharma | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77401 | SUPPL | 2024-02-06 |
| 77398 | SUPPL | 2024-02-05 |
| 71206 | ORIG | 2022-06-03 |
| 69035 | ORIG | 2021-10-20 |
| 69029 | ORIG | 2021-10-19 |