Home Applications 022563 Application 022563
Type NDA
Sponsor MAYNE PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SORILUX CALCIPOTRIENE AEROSOL, FOAM;TOPICAL 0.005% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N022563-001 SORILUX CALCIPOTRIENE 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022563-001 SORILUX 0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2010-10-06 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 199 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022563-001 8629128 2026-05-26 U-1280 Drug product 2014-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022563-001 8629128 2026-05-26 U-1767 Drug product 2014-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022563-001 8629128 2026-05-26 U-2662 Drug product 2014-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022563-001 8263580 2028-05-07 U-1280 Drug product 2012-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022563-001 8263580 2028-05-07 U-2662 Drug product 2012-09-21 5bbf6a4d5a75…
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.
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 51862-376 SORILUX calcipotriene Mayne Pharma NDA Current 51862-376 SORILUX calcipotriene Mayne Pharma NDA Current 51862-376 SORILUX calcipotriene Mayne Pharma NDA Current 51862-376 SORILUX calcipotriene Mayne Pharma NDA Current 51862-512 calcipotriene calcipotriene Mayne Pharma NDA Current 73308-357 CALCIPOTRIENE calcipotriene Ayurax NDA Current 73352-886 Calcipotriene 0.005% 60 gram Foam Calcipotriene 0.005% 60 gram Foam Trifluent Pharma LLC NDA Current 73352-886 Calcipotriene 0.005% 60 gram Foam Calcipotriene 0.005% 60 gram Foam Trifluent Pharma LLC NDA Current