Home Applications 209310 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209310-001 SINUVA MOMETASONE FUROATE 1.35MG IMPLANT / IMPLANTATION RLD, RS 2017-12-08
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209310-001 9585681 2026-04-04 U-2272 2018-04-26 N209310-001 7544192 2026-11-29 U-2272 2018-04-26 N209310-001 8025635 2027-06-12 U-2272 Drug product 2018-04-26 N209310-001 10357640 2031-10-03 U-2272 2019-12-06 N209310-001 8763222 2032-02-08 Drug product 2018-04-26 N209310-001 10406332 2034-03-13 Drug product 2019-12-06 N209310-001 10232152 2034-11-24 U-2272 Drug product 2019-12-06
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209310-001 SINUVA 1.35MG IMPLANT / IMPLANTATION RLD 2017-12-08 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 13 · 487 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209310-001 9585681 2026-04-04 U-2272 2018-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209310-001 7544192 2026-11-29 U-2272 2018-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209310-001 8025635 2027-06-12 U-2272 Drug product 2018-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209310-001 10357640 2031-10-03 U-2272 2019-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209310-001 8763222 2032-02-08 Drug product 2018-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209310-001 10406332 2034-03-13 Drug product 2019-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209310-001 10232152 2034-11-24 U-2272 Drug product 2019-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209310-001 9585681 2026-04-04 U-2272 2018-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209310-001 7544192 2026-11-29 U-2272 2018-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209310-001 8025635 2027-06-12 U-2272 Drug product 2018-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209310-001 10357640 2031-10-03 U-2272 2019-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209310-001 8763222 2032-02-08 Drug product 2018-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209310-001 10406332 2034-03-13 Drug product 2019-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209310-001 10232152 2034-11-24 U-2272 Drug product 2019-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209310-001 9585681 2026-04-04 U-2272 2018-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209310-001 7544192 2026-11-29 U-2272 2018-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209310-001 8025635 2027-06-12 U-2272 Drug product 2018-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209310-001 10357640 2031-10-03 U-2272 2019-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209310-001 8763222 2032-02-08 Drug product 2018-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209310-001 10406332 2034-03-13 Drug product 2019-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209310-001 10232152 2034-11-24 U-2272 Drug product 2019-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209310-001 9585681 2026-04-04 U-2272 2018-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209310-001 7544192 2026-11-29 U-2272 2018-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209310-001 8025635 2027-06-12 U-2272 Drug product 2018-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209310-001 10357640 2031-10-03 U-2272 2019-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209310-001 8763222 2032-02-08 Drug product 2018-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209310-001 10406332 2034-03-13 Drug product 2019-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209310-001 10232152 2034-11-24 U-2272 Drug product 2019-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209310-001 9585681 2026-04-04 U-2272 2018-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209310-001 7544192 2026-11-29 U-2272 2018-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209310-001 8025635 2027-06-12 U-2272 Drug product 2018-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209310-001 10357640 2031-10-03 U-2272 2019-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209310-001 8763222 2032-02-08 Drug product 2018-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209310-001 10406332 2034-03-13 Drug product 2019-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209310-001 10232152 2034-11-24 U-2272 Drug product 2019-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209310-001 7662141 2024-03-12 U-2272 2018-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209310-001 7713255 2024-03-12 U-2272 2018-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209310-001 7951130 2024-03-12 U-2272 2018-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209310-001 7951131 2024-03-12 U-2272 2018-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209310-001 7951133 2024-03-12 U-2272 2018-04-26 03ed91905a0d…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
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