Home Applications 202129 Application 202129
Type NDA
Sponsor COVIS PHARMA BV Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZETONNA CICLESONIDE AEROSOL, METERED;NASAL 0.037MG/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 N202129-001 ZETONNA CICLESONIDE 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20
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 N202129-001 8371292 2028-02-01 U-1357
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 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD 2012-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202129-001 ZETONNA 0.037MG/INH AEROSOL, METERED / NASAL RLD, RS 2012-01-20 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 2 · 43 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 · 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 63402-737 Zetonna ciclesonide Sunovion Pharmaceuticals NDA Current 63402-737 Zetonna ciclesonide Sunovion Pharmaceuticals Inc. NDA Current 66993-015 Ciclesonide ciclesonide Prasco Laboratories NDA AUTHORIZED GENERIC Current 70515-737 Zetonna ciclesonide Covis Pharma US, Inc NDA Current 70515-737 Zetonna ciclesonide Covis Pharma NDA Current 70515-737 Zetonna ciclesonide Covis Pharma US, Inc NDA Current 70515-737 Zetonna ciclesonide Covis Pharma NDA Current 70515-737 Zetonna ciclesonide Covis Pharma NDA Current