Application 210745

Type: NDA
Sponsor: AMGEN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OTEZLA XR	APREMILAST	TABLET, EXTENDED RELEASE;ORAL	75MG	Yes	Yes
002	OTEZLA	APREMILAST	TABLET;ORAL	10MG	No	No
003	OTEZLA	APREMILAST	TABLET;ORAL	20MG	No	No
005	OTEZLA	APREMILAST	TABLET;ORAL	30MG	No	No

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
N210745-001	OTEZLA XR	APREMILAST	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2025-08-29

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210745-001	7427638	2028-02-16		Drug substance, Drug product	2025-09-24
N210745-001	10092541	2034-05-29	U-2659		2025-09-24
N210745-001	11752129	2042-05-27	U-4264	Drug product	2025-09-24
N210745-001	11752129	2042-05-27	U-4265	Drug product	2025-09-24
N210745-001	11752129	2042-05-27	U-4266	Drug product	2025-09-24
N210745-001	11969409	2042-05-27		Drug product	2025-09-24
N210745-001	12427136	2042-05-27	U-1858		2025-10-28
N210745-001	12427136	2042-05-27	U-4290		2025-10-28
N210745-001	12427136	2042-05-27	U-4291		2025-10-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210745-001	ODE*	2026-07-19
N210745-001	M-299	2026-07-20
N210745-001	PED	2027-01-19
N210745-001	PED	2027-01-20

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.

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	N210745-001	OTEZLA XR	75MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2025-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	OTEZLA XR	75MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2025-08-29	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	OTEZLA XR	75MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2025-08-29	`a50c72e98297…`

Observed Orange Book patent history#

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	N210745-001	7427638	2028-02-16		Drug substance, Drug product	2025-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210745-001	10092541	2034-05-29	U-2659		2025-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210745-001	11752129	2042-05-27	U-4264	Drug product	2025-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210745-001	11752129	2042-05-27	U-4265	Drug product	2025-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210745-001	11752129	2042-05-27	U-4266	Drug product	2025-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210745-001	11969409	2042-05-27		Drug product	2025-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210745-001	12427136	2042-05-27	U-1858		2025-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210745-001	12427136	2042-05-27	U-4290		2025-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210745-001	12427136	2042-05-27	U-4291		2025-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	7427638	2028-02-16		Drug substance, Drug product	2025-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	10092541	2034-05-29	U-2659		2025-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	11752129	2042-05-27	U-4264	Drug product	2025-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	11752129	2042-05-27	U-4265	Drug product	2025-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	11752129	2042-05-27	U-4266	Drug product	2025-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	11969409	2042-05-27		Drug product	2025-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	12427136	2042-05-27	U-1858		2025-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	12427136	2042-05-27	U-4290		2025-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	12427136	2042-05-27	U-4291		2025-10-28	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	7427638	2028-02-16		Drug substance, Drug product	2025-09-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	10092541	2034-05-29	U-2659		2025-09-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	11752129	2042-05-27	U-4264	Drug product	2025-09-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	11752129	2042-05-27	U-4265	Drug product	2025-09-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	11752129	2042-05-27	U-4266	Drug product	2025-09-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	11969409	2042-05-27		Drug product	2025-09-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	12427136	2042-05-27	U-1858		2025-10-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	12427136	2042-05-27	U-4290		2025-10-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	12427136	2042-05-27	U-4291		2025-10-28	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210745-001	ODE*	2026-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210745-001	M-299	2026-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210745-001	PED	2027-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210745-001	PED	2027-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	ODE*	2026-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	M-299	2026-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	PED	2027-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210745-001	PED	2027-01-20	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	ODE*	2026-07-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	M-299	2026-07-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	PED	2027-01-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210745-001	PED	2027-01-20	`a50c72e98297…`

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
Otezla	APREMILAST	Amgen, Inc	f6b1f516-4972-4d82-bced-113e47b41cc5	2025-12-23	Warnings, Adverse reactions	Name fallback generic name: APREMILAST

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84037	ORIG	2025-11-03
84015	ORIG	2025-11-03
83268	ORIG	2025-09-03
83267	ORIG	2025-09-03
83251	ORIG	2025-09-02
83250	ORIG	2025-08-29