Home Applications 209022 Application 209022
Type NDA
Sponsor OPTINOSE US INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XHANCE FLUTICASONE PROPIONATE SPRAY, METERED;NASAL 0.093MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N209022-001 XHANCE FLUTICASONE PROPIONATE 0.093MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2017-09-18
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209022-001 12083270 2031-04-04 U-2133 2024-10-02 N209022-001 11554229 2036-02-23 U-2133 2023-02-08 N209022-001 12616806 2036-02-23 U-4524 2026-05-29 N209022-001 12616806 2036-02-23 U-4525 2026-05-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209022-001 I-940 2027-03-15
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 · 43 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 2026-09-14 22:38:34 2026-08 N209022-001 XHANCE 0.093MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2017-09-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209022-001 XHANCE 0.093MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2017-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209022-001 XHANCE 0.093MG SPRAY, METERED / NASAL RLD, RS 2017-09-18 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 14 · 555 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N209022-001 12083270 2031-04-04 U-2133 2024-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209022-001 11554229 2036-02-23 U-2133 2023-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209022-001 12616806 2036-02-23 U-4524 2026-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209022-001 12616806 2036-02-23 U-4525 2026-05-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209022-001 12083270 2031-04-04 U-2133 2024-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209022-001 11554229 2036-02-23 U-2133 2023-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209022-001 12616806 2036-02-23 U-4524 2026-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209022-001 12616806 2036-02-23 U-4525 2026-05-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209022-001 12083270 2031-04-04 U-2133 2024-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209022-001 11554229 2036-02-23 U-2133 2023-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209022-001 12083270 2031-04-04 U-2133 2024-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209022-001 11554229 2036-02-23 U-2133 2023-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209022-001 7975690 2025-12-29 U-2133 2017-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 10124132 2027-03-06 U-2133 Drug product 2018-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 11602603 2028-10-27 U-2133 Drug product 2023-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 10076615 2029-07-30 U-2133 2018-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 8550073 2029-10-22 Drug product 2017-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 8978647 2030-12-06 Drug product 2017-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 10252010 2031-02-07 Drug product 2019-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 12083270 2031-04-04 U-2133 2024-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 11033696 2033-05-20 Drug product 2021-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 10179216 2033-07-08 U-2133 Drug product 2019-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 10478574 2033-11-04 U-2133 2019-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 10076614 2034-10-20 Drug product 2018-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 10300229 2035-07-07 U-2133 Drug product 2019-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209022-001 11554229 2036-02-23 U-2133 2023-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 7975690 2025-12-29 U-2133 2017-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 10124132 2027-03-06 U-2133 Drug product 2018-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 11602603 2028-10-27 U-2133 Drug product 2023-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 10076615 2029-07-30 U-2133 2018-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 8550073 2029-10-22 Drug product 2017-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 8978647 2030-12-06 Drug product 2017-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 10252010 2031-02-07 Drug product 2019-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 12083270 2031-04-04 U-2133 2024-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 11033696 2033-05-20 Drug product 2021-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 10179216 2033-07-08 U-2133 Drug product 2019-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 10478574 2033-11-04 U-2133 2019-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 10076614 2034-10-20 Drug product 2018-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 10300229 2035-07-07 U-2133 Drug product 2019-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209022-001 11554229 2036-02-23 U-2133 2023-02-08 fd3edfee7708…
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 · 2 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71143-375 XHANCE fluticasone propionate OptiNose US, Inc. NDA Current 71143-375 XHANCE fluticasone propionate OptiNose US, Inc. NDA Current 71143-375 XHANCE fluticasone propionate OptiNose US, Inc. NDA Current 71143-375 XHANCE fluticasone propionate OptiNose US, Inc. NDA Current 71143-375 XHANCE fluticasone propionate OptiNose US, Inc. NDA Current 71143-375 XHANCE fluticasone propionate OptiNose US, Inc. NDA Current 71143-375 XHANCE fluticasone propionate OptiNose US, Inc. NDA Current 71143-375 XHANCE fluticasone propionate OptiNose US, Inc. NDA Current