Home Applications 022004 Application 022004
Type NDA
Sponsor COVIS PHARMA BV Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OMNARIS CICLESONIDE SPRAY, METERED;NASAL 0.05MG/INH 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 N022004-001 OMNARIS CICLESONIDE 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022004-001 8371292 2028-02-01 U-1356
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 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022004-001 OMNARIS 0.05MG/INH SPRAY, METERED / NASAL RLD, RS 2006-10-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022004-001 OMNARIS 0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2006-10-20 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 2 · 63 observed states.
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.
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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63402-701 Omnaris ciclesonide Sunovion Pharmaceuticals NDA Current 63402-701 Omnaris ciclesonide Sunovion Pharmaceuticals Inc. NDA Current 70515-701 Omnaris ciclesonide Covis Pharma NDA Current 70515-701 Omnaris ciclesonide Covis Pharma NDA Current 70515-701 Omnaris ciclesonide Covis Pharma US, Inc NDA Current 70515-701 Omnaris ciclesonide Covis Pharma NDA Current 70515-701 Omnaris ciclesonide Covis Pharma US, Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 58699 SUPPL 2019-05-14 58645 SUPPL 2019-05-13 6663 SUPPL 2016-03-21 29049 SUPPL 2013-03-26 16746 SUPPL 2013-03-26 38066 SUPPL 2010-05-17 6662 SUPPL 2010-05-12 6661 SUPPL 2010-05-12 16745 SUPPL 2007-11-26 6660 SUPPL 2007-11-26 21900 ORIG 2006-12-22 6659 ORIG 2006-10-26 38065 ORIG 2006-10-23