Skip to contentApplication 215092
- Type
- NDA
- Sponsor
- SANTEN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OMLONTI | OMIDENEPAG ISOPROPYL | SOLUTION;OPHTHALMIC | 0.002%(0.02MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65086-002 | Omlonti | omidenepag isopropyl | Santen Incorporated | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72425 | ORIG | 2022-10-20 |
| 72146 | ORIG | 2022-09-23 |
| 72142 | ORIG | 2022-09-23 |