Application 215985

Type: NDA
Sponsor: ARCUTIS BIOTHERAPEUTICS, INC.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZORYVE	ROFUMILAST	CREAM;TOPICAL	0.3%	No	No
002	ZORYVE	ROFLUMILAST	CREAM;TOPICAL	0.15%	Yes	Yes
003	ZORYVE	ROFLUMILAST	CREAM;TOPICAL	0.05%	Yes	Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215985-001	ZORYVE	ROFLUMILAST	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29
N215985-002	ZORYVE	ROFLUMILAST	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09
N215985-003	ZORYVE	ROFLUMILAST	0.05%	CREAM / TOPICAL	RLD, RS	2025-10-04

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215985-001	10940142	2037-06-07		Drug product	2022-08-19
N215985-001	11793796	2037-06-07		Drug product	2023-10-24
N215985-001	11819496	2037-06-07	U-3748		2023-11-21
N215985-001	11992480	2037-06-07	U-3748		2024-06-26
N215985-001	12005051	2037-06-07	U-3748		2024-07-09
N215985-001	12005052	2037-06-07		Drug product	2024-07-09
N215985-001	12011437	2037-06-07		Drug product	2024-07-09
N215985-001	12016848	2037-06-07		Drug product	2024-07-09
N215985-001	12042487	2037-06-07		Drug product	2024-08-21
N215985-001	12220409	2037-06-07		Drug product	2025-03-07
N215985-001	12257242	2037-06-07		Drug product	2025-04-22
N215985-001	12310956	2037-06-07	U-3748		2025-06-26
N215985-001	12336983	2037-06-07		Drug product	2025-07-22
N215985-001	9884050	2037-06-07		Drug product	2022-08-19
N215985-001	9907788	2037-06-07	U-3408		2022-08-19
N215985-001	9907788	2037-06-07	U-3712		2022-08-19
N215985-001	11129818	2037-08-25	U-3408		2022-08-19
N215985-001	11129818	2037-08-25	U-3712		2022-08-19
N215985-002	10940142	2037-06-07		Drug product	2024-08-08
N215985-002	11793796	2037-06-07		Drug product	2024-08-08
N215985-002	11819496	2037-06-07	U-3970		2024-08-08
N215985-002	11992480	2037-06-07	U-3970		2024-08-08
N215985-002	12005051	2037-06-07	U-3970		2024-08-08
N215985-002	12005052	2037-06-07		Drug product	2024-08-08
N215985-002	12011437	2037-06-07		Drug product	2024-08-08
N215985-002	12016848	2037-06-07		Drug product	2024-08-08
N215985-002	12042487	2037-06-07		Drug product	2024-08-08
N215985-002	12220409	2037-06-07		Drug product	2025-03-07
N215985-002	12257242	2037-06-07		Drug product	2025-04-22
N215985-002	12310956	2037-06-07	U-3970		2025-06-26
N215985-002	12336983	2037-06-07		Drug product	2025-07-22
N215985-002	9884050	2037-06-07		Drug product	2024-08-08
N215985-002	9907788	2037-06-07	U-3970		2024-08-08
N215985-002	11129818	2037-08-25	U-3970		2024-08-08
N215985-003	10940142	2037-06-07		Drug product	2025-11-04
N215985-003	11793796	2037-06-07		Drug product	2025-11-04
N215985-003	11819496	2037-06-07	U-4301		2025-11-04
N215985-003	11992480	2037-06-07	U-4301		2025-11-04
N215985-003	12005051	2037-06-07	U-4301		2025-11-04
N215985-003	12005052	2037-06-07		Drug product	2025-11-04
N215985-003	12011437	2037-06-07		Drug product	2025-11-04
N215985-003	12016848	2037-06-07		Drug product	2025-11-04
N215985-003	12042487	2037-06-07		Drug product	2025-11-04
N215985-003	12220409	2037-06-07		Drug product	2025-11-04
N215985-003	12257242	2037-06-07		Drug product	2025-11-04
N215985-003	12310956	2037-06-07	U-4301		2025-11-04
N215985-003	12336983	2037-06-07		Drug product	2025-11-04
N215985-003	9884050	2037-06-07		Drug product	2025-11-04
N215985-003	9907788	2037-06-07	U-4301		2025-11-04
N215985-003	11129818	2037-08-25	U-4301		2025-11-04

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215985-001	NPP	2026-10-05
N215985-002	NS	2027-07-09
N215985-003	NS	2028-10-04

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	ZORYVE	0.05%	CREAM / TOPICAL	RLD, RS	2025-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-003	ZORYVE	0.05%	CREAM / TOPICAL	RLD, RS	2025-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 473 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	N215985-001	10940142	2037-06-07		Drug product	2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	11793796	2037-06-07		Drug product	2023-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	11819496	2037-06-07	U-3748		2023-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	11992480	2037-06-07	U-3748		2024-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12005051	2037-06-07	U-3748		2024-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12005052	2037-06-07		Drug product	2024-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12011437	2037-06-07		Drug product	2024-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12016848	2037-06-07		Drug product	2024-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12042487	2037-06-07		Drug product	2024-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12220409	2037-06-07		Drug product	2025-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12257242	2037-06-07		Drug product	2025-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12310956	2037-06-07	U-3748		2025-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12336983	2037-06-07		Drug product	2025-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	9884050	2037-06-07		Drug product	2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	9907788	2037-06-07	U-3712		2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	9907788	2037-06-07	U-3408		2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	11129818	2037-08-25	U-3712		2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	11129818	2037-08-25	U-3408		2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	10940142	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	11793796	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	11819496	2037-06-07	U-3970		2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	11992480	2037-06-07	U-3970		2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12005051	2037-06-07	U-3970		2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12005052	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12011437	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12016848	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12042487	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12220409	2037-06-07		Drug product	2025-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12257242	2037-06-07		Drug product	2025-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12310956	2037-06-07	U-3970		2025-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12336983	2037-06-07		Drug product	2025-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	9884050	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	9907788	2037-06-07	U-3970		2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	11129818	2037-08-25	U-3970		2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	10940142	2037-06-07		Drug product	2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	11793796	2037-06-07		Drug product	2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	11819496	2037-06-07	U-4301		2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	11992480	2037-06-07	U-4301		2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	12005051	2037-06-07	U-4301		2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	12005052	2037-06-07		Drug product	2025-11-04	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215985-001	NPP	2026-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	NS	2027-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	NS	2028-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-001	NP	2025-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-001	NPP	2026-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-002	NS	2027-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-003	NS	2028-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215985-001	NP	2025-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215985-001	NPP	2026-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215985-002	NS	2027-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215985-001	NP	2025-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215985-001	NPP	2026-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215985-002	NS	2027-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215985-001	NP	2025-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215985-001	NPP	2026-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215985-002	NS	2027-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215985-001	NP	2025-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215985-001	NPP	2026-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215985-002	NS	2027-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215985-001	NP	2025-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215985-001	NPP	2026-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215985-002	NS	2027-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215985-001	NP	2025-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215985-001	NPP	2026-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215985-002	NS	2027-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215985-001	NP	2025-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215985-001	NPP	2026-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215985-002	NS	2027-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215985-001	NP	2025-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215985-001	NPP	2026-10-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215985-002	NS	2027-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215985-001	NP	2025-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215985-001	NPP	2026-10-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215985-002	NS	2027-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215985-001	NP	2025-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215985-001	NPP	2026-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215985-001	NP	2025-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215985-001	NPP	2026-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215985-001	NP	2025-07-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215985-001	NPP	2026-10-05	`8072bd15b7f6…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZORYVE	ROFLUMILAST	Arcutis Biotherapeutics, Inc.	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	2026-07-02	Adverse reactions	Exact 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
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
80610-130	roflumilast	roflumilast	Arcutis Biotherapeutics, Inc.	NDA	Current
80610-130	ZORYVE	roflumilast	Arcutis Biotherapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83674	SUPPL	2025-10-06
83667	SUPPL	2025-10-06
79072	SUPPL	2024-12-03
79032	SUPPL	2024-07-10
75690	SUPPL	2023-10-10
75680	SUPPL	2023-10-06
72904	ORIG	2022-12-15
71690	ORIG	2022-08-01
71675	ORIG	2022-08-01