Home Applications 021978 Application 021978
Type NDA
Sponsor ALMIRALL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VERDESO DESONIDE AEROSOL, FOAM;TOPICAL 0.05% 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 N021978-001 VERDESO DESONIDE 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19
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 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05
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 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD 2006-09-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021978-001 VERDESO 0.05% AEROSOL, FOAM / TOPICAL RLD, RS 2006-09-19 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 4 · 129 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 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021978-001 9492384 2025-08-31 U-1412 Drug product 2016-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021978-001 9492384 2025-08-31 U-1412 Drug product 2016-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021978-001 9492384 2025-08-31 U-1412 Drug product 2016-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021978-001 9492384 2025-08-31 U-1412 Drug product 2016-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021978-001 9492384 2025-08-31 U-1412 Drug product 2016-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021978-001 9492384 2025-08-31 U-1412 Drug product 2016-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021978-001 9492384 2025-08-31 U-1412 Drug product 2016-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021978-001 9492384 2025-08-31 U-1412 Drug product 2016-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021978-001 9492384 2025-08-31 U-1412 Drug product 2016-12-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021978-001 9492384 2025-08-31 U-1412 Drug product 2016-12-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021978-001 9492384 2025-08-31 U-1412 Drug product 2016-12-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021978-001 9492384 2025-08-31 U-1412 Drug product 2016-12-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021978-001 8460641 2027-08-13 U-1412 Drug product 2013-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021978-001 8962000 2025-08-31 U-1412 Drug product 2015-03-25 8072bd15b7f6…
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 2 of 2 · 23 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16110-111 Verdeso desonide Almirall, LLC NDA Current 16110-111 Verdeso desonide Almirall, LLC NDA Current 16110-111 Verdeso desonide Almirall, LLC NDA Current 16110-111 Verdeso desonide Aqua Pharmaceuticals NDA Current 16110-111 Verdeso desonide Aqua Pharmaceuticals NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 62368 SUPPL 2020-03-31 58359 SUPPL 2019-04-19 58340 SUPPL 2019-04-16 37988 SUPPL 2013-04-09 28970 SUPPL 2013-04-03 6581 SUPPL 2011-08-26 37987 SUPPL 2011-08-22 16686 SUPPL 2010-05-03 28969 SUPPL 2010-04-28 44661 ORIG 2008-09-05 21893 ORIG 2008-09-05 16685 ORIG 2006-09-20 6580 ORIG 2006-09-20