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 42.

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 · 56 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	11819496	2037-06-07	U-4578		2023-11-21
N215985-001	11992480	2037-06-07	U-3748		2024-06-26
N215985-001	11992480	2037-06-07	U-4578		2024-06-26
N215985-001	12005051	2037-06-07	U-3748		2024-07-09
N215985-001	12005051	2037-06-07	U-4578		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	12310956	2037-06-07	U-4578		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	9907788	2037-06-07	U-4578		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
N215985-001	11129818	2037-08-25	U-4578		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 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215985-001	NPP	2026-10-05
N215985-001	NPP	2029-06-29
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 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-003	ZORYVE	0.05%	CREAM / TOPICAL	RLD, RS	2025-10-04	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 529 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215985-001	10940142	2037-06-07		Drug product	2022-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	11793796	2037-06-07		Drug product	2023-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	11819496	2037-06-07	U-3748		2023-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	11819496	2037-06-07	U-4578		2023-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	11992480	2037-06-07	U-3748		2024-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	11992480	2037-06-07	U-4578		2024-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	12005051	2037-06-07	U-3748		2024-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	12005051	2037-06-07	U-4578		2024-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	12005052	2037-06-07		Drug product	2024-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	12011437	2037-06-07		Drug product	2024-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	12016848	2037-06-07		Drug product	2024-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	12042487	2037-06-07		Drug product	2024-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	12220409	2037-06-07		Drug product	2025-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	12257242	2037-06-07		Drug product	2025-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	12310956	2037-06-07	U-3748		2025-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	12310956	2037-06-07	U-4578		2025-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	12336983	2037-06-07		Drug product	2025-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	9884050	2037-06-07		Drug product	2022-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	9907788	2037-06-07	U-3712		2022-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	9907788	2037-06-07	U-3408		2022-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	9907788	2037-06-07	U-4578		2022-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	11129818	2037-08-25	U-3712		2022-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	11129818	2037-08-25	U-3408		2022-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	11129818	2037-08-25	U-4578		2022-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	10940142	2037-06-07		Drug product	2024-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	11793796	2037-06-07		Drug product	2024-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	11819496	2037-06-07	U-3970		2024-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	11992480	2037-06-07	U-3970		2024-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	12005051	2037-06-07	U-3970		2024-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	12005052	2037-06-07		Drug product	2024-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	12011437	2037-06-07		Drug product	2024-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	12016848	2037-06-07		Drug product	2024-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	12042487	2037-06-07		Drug product	2024-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	12220409	2037-06-07		Drug product	2025-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	12257242	2037-06-07		Drug product	2025-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	12310956	2037-06-07	U-3970		2025-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	12336983	2037-06-07		Drug product	2025-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	9884050	2037-06-07		Drug product	2024-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	9907788	2037-06-07	U-3970		2024-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	11129818	2037-08-25	U-3970		2024-08-08	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N215985-001	NPP	2026-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-001	NPP	2029-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-002	NS	2027-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215985-003	NS	2028-10-04	`caaa826d4ba7…`
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…`

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.

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	2026-07-20	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