Home Applications 021658 Application 021658
Type NDA
Sponsor COVIS PHARMA BV Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 ALVESCO CICLESONIDE AEROSOL, METERED;INHALATION 0.08MG/INH Yes Yes 003 ALVESCO CICLESONIDE AEROSOL, METERED;INHALATION 0.16MG/INH Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021658-002 ALVESCO CICLESONIDE 0.08MG/INH AEROSOL, METERED / INHALATION RLD, RS 2008-01-10 N021658-003 ALVESCO CICLESONIDE 0.16MG/INH AEROSOL, METERED / INHALATION RLD, RS 2008-01-10
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021658-002 8371292 2028-02-01 U-1355 N021658-003 8371292 2028-02-01 U-1355
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 3 of 3 · 88 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 2022-10-28 04:53 UTC 2022-10 N021658-002 ALVESCO 0.08MG/INH AEROSOL, METERED / INHALATION RLD, RS 2008-01-10 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021658-003 ALVESCO 0.16MG/INH AEROSOL, METERED / INHALATION RLD, RS 2008-01-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021658-002 ALVESCO 0.08MG/INH AEROSOL, METERED / INHALATION RLD, RS 2008-01-10 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021658-003 ALVESCO 0.16MG/INH AEROSOL, METERED / INHALATION RLD, RS 2008-01-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021658-002 ALVESCO 0.08MG/INH AEROSOL, METERED / INHALATION RLD, RS 2008-01-10 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021658-003 ALVESCO 0.16MG/INH AEROSOL, METERED / INHALATION RLD, RS 2008-01-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021658-002 ALVESCO 0.08MG/INH AEROSOL, METERED / INHALATION RLD, RS 2008-01-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021658-003 ALVESCO 0.16MG/INH AEROSOL, METERED / INHALATION RLD, RS 2008-01-10 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N021658-002 8371292 2028-02-01 U-1355 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021658-003 8371292 2028-02-01 U-1355 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021658-002 8371292 2028-02-01 U-1355 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021658-003 8371292 2028-02-01 U-1355 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021658-002 8371292 2028-02-01 U-1355 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021658-003 8371292 2028-02-01 U-1355 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021658-002 8371292 2028-02-01 U-1355 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021658-003 8371292 2028-02-01 U-1355 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021658-002 8371292 2028-02-01 U-1355 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021658-003 8371292 2028-02-01 U-1355 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021658-002 8371292 2028-02-01 U-1355 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021658-003 8371292 2028-02-01 U-1355 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021658-002 8371292 2028-02-01 U-1355 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021658-003 8371292 2028-02-01 U-1355 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021658-002 8371292 2028-02-01 U-1355 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021658-003 8371292 2028-02-01 U-1355 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021658-002 8371292 2028-02-01 U-1355 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021658-003 8371292 2028-02-01 U-1355 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021658-002 8371292 2028-02-01 U-1355 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021658-003 8371292 2028-02-01 U-1355 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021658-002 8371292 2028-02-01 U-1355 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021658-003 8371292 2028-02-01 U-1355 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021658-002 8371292 2028-02-01 U-1355 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021658-003 8371292 2028-02-01 U-1355 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021658-002 8371292 2028-02-01 U-1355 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021658-003 8371292 2028-02-01 U-1355 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021658-002 8371292 2028-02-01 U-1355 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021658-003 8371292 2028-02-01 U-1355 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021658-002 8371292 2028-02-01 U-1355 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021658-003 8371292 2028-02-01 U-1355 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021658-002 8371292 2028-02-01 U-1355 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021658-003 8371292 2028-02-01 U-1355 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021658-002 8371292 2028-02-01 U-1355 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021658-003 8371292 2028-02-01 U-1355 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021658-002 8371292 2028-02-01 U-1355 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021658-003 8371292 2028-02-01 U-1355 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021658-002 8371292 2028-02-01 U-1355 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021658-003 8371292 2028-02-01 U-1355 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021658-002 8371292 2028-02-01 U-1355 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021658-003 8371292 2028-02-01 U-1355 4b0b4de00fa7…
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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63402-711 Alvesco ciclesonide Sunovion Pharmaceuticals NDA Current 63402-711 Alvesco ciclesonide Sunovion Pharmaceuticals Inc. NDA Current 63402-712 Alvesco ciclesonide Sunovion Pharmaceuticals NDA Current 63402-712 Alvesco ciclesonide Sunovion Pharmaceuticals Inc. NDA Current 66993-571 Ciclesonide ciclesonide Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-572 Ciclesonide ciclesonide Prasco Laboratories NDA AUTHORIZED GENERIC Current 70515-711 Alvesco ciclesonide Covis Pharma NDA Current 70515-711 Alvesco ciclesonide Covis Pharma US, Inc NDA Current 70515-711 Alvesco ciclesonide Covis Pharma US, Inc NDA Current 70515-711 Alvesco ciclesonide Covis Pharma NDA Current 70515-711 Alvesco ciclesonide Covis Pharma NDA Current 70515-711 Alvesco ciclesonide Covis Pharma NDA Current 70515-712 Alvesco ciclesonide Covis Pharma NDA Current 70515-712 Alvesco ciclesonide Covis Pharma US, Inc NDA Current 70515-712 Alvesco ciclesonide Covis Pharma US, Inc NDA Current 70515-712 Alvesco ciclesonide Covis Pharma NDA Current 70515-712 Alvesco ciclesonide Covis Pharma NDA Current 70515-712 Alvesco ciclesonide Covis Pharma NDA Current