Application 215985

Type
NDA
Sponsor
ARCUTIS BIOTHERAPEUTICS, INC.

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZORYVEROFUMILASTCREAM;TOPICAL0.3%NoNo
002ZORYVEROFLUMILASTCREAM;TOPICAL0.15%YesYes
003ZORYVEROFLUMILASTCREAM;TOPICAL0.05%YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215985-001ZORYVEROFLUMILAST0.3%CREAM / TOPICALRLD, RS2022-07-29
N215985-002ZORYVEROFLUMILAST0.15%CREAM / TOPICALRLD, RS2024-07-09
N215985-003ZORYVEROFLUMILAST0.05%CREAM / TOPICALRLD, RS2025-10-04

Orange Book patents#

Current patent rows page 1 of 1 · 50 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215985-001109401422037-06-07Drug product2022-08-19
N215985-001117937962037-06-07Drug product2023-10-24
N215985-001118194962037-06-07U-37482023-11-21
N215985-001119924802037-06-07U-37482024-06-26
N215985-001120050512037-06-07U-37482024-07-09
N215985-001120050522037-06-07Drug product2024-07-09
N215985-001120114372037-06-07Drug product2024-07-09
N215985-001120168482037-06-07Drug product2024-07-09
N215985-001120424872037-06-07Drug product2024-08-21
N215985-001122204092037-06-07Drug product2025-03-07
N215985-001122572422037-06-07Drug product2025-04-22
N215985-001123109562037-06-07U-37482025-06-26
N215985-001123369832037-06-07Drug product2025-07-22
N215985-00198840502037-06-07Drug product2022-08-19
N215985-00199077882037-06-07U-34082022-08-19
N215985-00199077882037-06-07U-37122022-08-19
N215985-001111298182037-08-25U-34082022-08-19
N215985-001111298182037-08-25U-37122022-08-19
N215985-002109401422037-06-07Drug product2024-08-08
N215985-002117937962037-06-07Drug product2024-08-08
N215985-002118194962037-06-07U-39702024-08-08
N215985-002119924802037-06-07U-39702024-08-08
N215985-002120050512037-06-07U-39702024-08-08
N215985-002120050522037-06-07Drug product2024-08-08
N215985-002120114372037-06-07Drug product2024-08-08
N215985-002120168482037-06-07Drug product2024-08-08
N215985-002120424872037-06-07Drug product2024-08-08
N215985-002122204092037-06-07Drug product2025-03-07
N215985-002122572422037-06-07Drug product2025-04-22
N215985-002123109562037-06-07U-39702025-06-26
N215985-002123369832037-06-07Drug product2025-07-22
N215985-00298840502037-06-07Drug product2024-08-08
N215985-00299077882037-06-07U-39702024-08-08
N215985-002111298182037-08-25U-39702024-08-08
N215985-003109401422037-06-07Drug product2025-11-04
N215985-003117937962037-06-07Drug product2025-11-04
N215985-003118194962037-06-07U-43012025-11-04
N215985-003119924802037-06-07U-43012025-11-04
N215985-003120050512037-06-07U-43012025-11-04
N215985-003120050522037-06-07Drug product2025-11-04
N215985-003120114372037-06-07Drug product2025-11-04
N215985-003120168482037-06-07Drug product2025-11-04
N215985-003120424872037-06-07Drug product2025-11-04
N215985-003122204092037-06-07Drug product2025-11-04
N215985-003122572422037-06-07Drug product2025-11-04
N215985-003123109562037-06-07U-43012025-11-04
N215985-003123369832037-06-07Drug product2025-11-04
N215985-00398840502037-06-07Drug product2025-11-04
N215985-00399077882037-06-07U-43012025-11-04
N215985-003111298182037-08-25U-43012025-11-04

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215985-001NPP2026-10-05
N215985-002NS2027-07-09
N215985-003NS2028-10-04

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002ZORYVE0.15%CREAM / TOPICALRLD, RS2024-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-003ZORYVE0.05%CREAM / TOPICALRLD, RS2025-10-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215985-002ZORYVE0.15%CREAM / TOPICALRLD, RS2024-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215985-003ZORYVE0.05%CREAM / TOPICALRLD, RS2025-10-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215985-002ZORYVE0.15%CREAM / TOPICALRLD, RS2024-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215985-002ZORYVE0.15%CREAM / TOPICALRLD, RS2024-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215985-002ZORYVE0.15%CREAM / TOPICALRLD, RS2024-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215985-002ZORYVE0.15%CREAM / TOPICALRLD, RS2024-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215985-002ZORYVE0.15%CREAM / TOPICALRLD, RS2024-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215985-002ZORYVE0.15%CREAM / TOPICALRLD, RS2024-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215985-002ZORYVE0.15%CREAM / TOPICALRLD, RS2024-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N215985-002ZORYVE0.15%CREAM / TOPICALRLD, RS2024-07-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215985-002ZORYVE0.15%CREAM / TOPICALRLD, RS2024-07-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-298072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29e64feba35796…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 12 · 473 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N215985-001109401422037-06-07Drug product2022-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001117937962037-06-07Drug product2023-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001118194962037-06-07U-37482023-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001119924802037-06-07U-37482024-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001120050512037-06-07U-37482024-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001120050522037-06-07Drug product2024-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001120114372037-06-07Drug product2024-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001120168482037-06-07Drug product2024-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001120424872037-06-07Drug product2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001122204092037-06-07Drug product2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001122572422037-06-07Drug product2025-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001123109562037-06-07U-37482025-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001123369832037-06-07Drug product2025-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-00198840502037-06-07Drug product2022-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-00199077882037-06-07U-37122022-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-00199077882037-06-07U-34082022-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001111298182037-08-25U-37122022-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-001111298182037-08-25U-34082022-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002109401422037-06-07Drug product2024-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002117937962037-06-07Drug product2024-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002118194962037-06-07U-39702024-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002119924802037-06-07U-39702024-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002120050512037-06-07U-39702024-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002120050522037-06-07Drug product2024-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002120114372037-06-07Drug product2024-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002120168482037-06-07Drug product2024-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002120424872037-06-07Drug product2024-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002122204092037-06-07Drug product2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002122572422037-06-07Drug product2025-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002123109562037-06-07U-39702025-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002123369832037-06-07Drug product2025-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-00298840502037-06-07Drug product2024-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-00299077882037-06-07U-39702024-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002111298182037-08-25U-39702024-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-003109401422037-06-07Drug product2025-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-003117937962037-06-07Drug product2025-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-003118194962037-06-07U-43012025-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-003119924802037-06-07U-43012025-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-003120050512037-06-07U-43012025-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-003120050522037-06-07Drug product2025-11-04011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N215985-001NPP2026-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-002NS2027-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215985-003NS2028-10-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215985-001NP2025-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215985-001NPP2026-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215985-002NS2027-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215985-003NS2028-10-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N215985-001NP2025-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215985-001NPP2026-10-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215985-002NS2027-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215985-001NP2025-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215985-001NPP2026-10-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215985-002NS2027-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215985-001NP2025-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215985-001NPP2026-10-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215985-002NS2027-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215985-001NP2025-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215985-001NPP2026-10-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215985-002NS2027-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215985-001NP2025-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215985-001NPP2026-10-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215985-002NS2027-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215985-001NP2025-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215985-001NPP2026-10-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215985-002NS2027-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215985-001NP2025-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215985-001NPP2026-10-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215985-002NS2027-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215985-001NP2025-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N215985-001NPP2026-10-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N215985-002NS2027-07-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215985-001NP2025-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215985-001NPP2026-10-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215985-002NS2027-07-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215985-001NP2025-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215985-001NPP2026-10-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215985-001NP2025-07-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215985-001NPP2026-10-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215985-001NP2025-07-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N215985-001NPP2026-10-058072bd15b7f6…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZORYVEROFLUMILASTArcutis Biotherapeutics, Inc.ec1bb0d1-f38a-4080-831a-68791d1d1fdb2026-07-02Adverse reactionsExact identifier
application applno (NDA): 215985
application number: NDA215985
ndc (product): 80610-130

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
80610-130roflumilastroflumilastArcutis Biotherapeutics, Inc.NDACurrent
80610-130ZORYVEroflumilastArcutis Biotherapeutics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83674SUPPL 2025-10-06
83667SUPPL 2025-10-06
79072SUPPL 2024-12-03
79032SUPPL 2024-07-10
75690SUPPL 2023-10-10
75680SUPPL 2023-10-06
72904ORIG2022-12-15
71690ORIG2022-08-01
71675ORIG2022-08-01