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Application 209310
- Type
- NDA
- Sponsor
- INTERSECT ENT INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SINUVA | MOMETASONE FUROATE | IMPLANT;IMPLANTATION | 1.35MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10599-003 | Sinuva | mometasone furoate | Intersect ENT, Inc. | NDA | Current |
| 10599-003 | Sinuva | mometasone furoate | Intersect ENT, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73280 | SUPPL | 2023-01-24 |
| 73268 | SUPPL | 2023-01-23 |
| 62743 | SUPPL | 2020-04-29 |
| 56727 | ORIG | 2018-12-13 |
| 51063 | SUPPL | 2018-01-17 |
| 51051 | SUPPL | 2018-01-16 |
| 50652 | ORIG | 2017-12-11 |
| 50651 | ORIG | 2017-12-11 |