Application 205437

Type: NDA
Sponsor: AMGEN INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	RLD / RS	Approval date
N205437-001	OTEZLA	APREMILAST	10MG	TABLET / ORAL	AB	RLD	2014-03-21
N205437-002	OTEZLA	APREMILAST	20MG	TABLET / ORAL	AB	RLD	2014-03-21
N205437-003	OTEZLA	APREMILAST	30MG	TABLET / ORAL	AB	RLD, RS	2014-03-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N205437-001	AB
N205437-002	AB
N205437-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 36 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205437-001	7427638	2028-02-16		Drug substance, Drug product	2014-04-15
N205437-001	7427638*PED	2028-08-16		Pediatric extension
N205437-001	12576034	2033-11-30	U-1858	Drug product	2026-04-16
N205437-001	12576034	2033-11-30	U-4290	Drug product	2026-04-16
N205437-001	12576034	2033-11-30	U-4291	Drug product	2026-04-16
N205437-001	10092541	2034-05-29	U-2403		2018-10-09
N205437-001	10092541	2034-05-29	U-2659		2018-10-09
N205437-001	9872854	2034-05-29	U-2232		2018-02-21
N205437-001	9872854	2034-05-29	U-2233		2018-02-21
N205437-001	12576034*PED	2034-05-30		Pediatric extension
N205437-001	10092541*PED	2034-11-29		Pediatric extension
N205437-001	9872854*PED	2034-11-29		Pediatric extension
N205437-002	7427638	2028-02-16		Drug substance, Drug product	2014-04-15
N205437-002	7427638*PED	2028-08-16		Pediatric extension
N205437-002	12576034	2033-11-30	U-1858	Drug product	2026-04-16
N205437-002	12576034	2033-11-30	U-4290	Drug product	2026-04-16
N205437-002	12576034	2033-11-30	U-4291	Drug product	2026-04-16
N205437-002	10092541	2034-05-29	U-2403		2018-10-09
N205437-002	10092541	2034-05-29	U-2659		2018-10-09
N205437-002	9872854	2034-05-29	U-2232		2018-02-21
N205437-002	9872854	2034-05-29	U-2233		2018-02-21
N205437-002	12576034*PED	2034-05-30		Pediatric extension
N205437-002	10092541*PED	2034-11-29		Pediatric extension
N205437-002	9872854*PED	2034-11-29		Pediatric extension
N205437-003	7427638	2028-02-16		Drug substance, Drug product	2014-04-15
N205437-003	7427638*PED	2028-08-16		Pediatric extension
N205437-003	12576034	2033-11-30	U-1858	Drug product	2026-04-16
N205437-003	12576034	2033-11-30	U-4290	Drug product	2026-04-16
N205437-003	12576034	2033-11-30	U-4291	Drug product	2026-04-16
N205437-003	10092541	2034-05-29	U-2403		2018-10-09
N205437-003	10092541	2034-05-29	U-2659		2018-10-09
N205437-003	9872854	2034-05-29	U-2232		2018-02-21
N205437-003	9872854	2034-05-29	U-2233		2018-02-21
N205437-003	12576034*PED	2034-05-30		Pediatric extension
N205437-003	10092541*PED	2034-11-29		Pediatric extension
N205437-003	9872854*PED	2034-11-29		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 18 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205437-001	ODE-248	2026-07-19
N205437-001	M-299	2026-07-20
N205437-001	PED	2027-01-19
N205437-001	PED	2027-01-20
N205437-001	NPP	2027-04-25
N205437-001	PED	2027-10-25
N205437-002	ODE-248	2026-07-19
N205437-002	M-299	2026-07-20
N205437-002	PED	2027-01-19
N205437-002	PED	2027-01-20
N205437-002	NPP	2027-04-25
N205437-002	PED	2027-10-25
N205437-003	ODE-248	2026-07-19
N205437-003	M-299	2026-07-20
N205437-003	PED	2027-01-19
N205437-003	PED	2027-01-20
N205437-003	NPP	2027-04-25
N205437-003	PED	2027-10-25

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 2 of 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205437-002	OTEZLA	20MG	TABLET / ORAL	AB	RLD	2014-03-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205437-003	OTEZLA	30MG	TABLET / ORAL	AB	RLD, RS	2014-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205437-001	OTEZLA	10MG	TABLET / ORAL	AB	RLD	2014-03-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205437-002	OTEZLA	20MG	TABLET / ORAL	AB	RLD	2014-03-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205437-003	OTEZLA	30MG	TABLET / ORAL	AB	RLD, RS	2014-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205437-001	OTEZLA	10MG	TABLET / ORAL	AB	RLD	2014-03-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205437-002	OTEZLA	20MG	TABLET / ORAL	AB	RLD	2014-03-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205437-003	OTEZLA	30MG	TABLET / ORAL	AB	RLD, RS	2014-03-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205437-001	OTEZLA	10MG	TABLET / ORAL	AB	RLD	2014-03-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205437-002	OTEZLA	20MG	TABLET / ORAL	AB	RLD	2014-03-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205437-003	OTEZLA	30MG	TABLET / ORAL	AB	RLD, RS	2014-03-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205437-001	OTEZLA	10MG	TABLET / ORAL	AB	RLD	2014-03-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205437-002	OTEZLA	20MG	TABLET / ORAL	AB	RLD	2014-03-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205437-003	OTEZLA	30MG	TABLET / ORAL	AB	RLD, RS	2014-03-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205437-001	OTEZLA	10MG	TABLET / ORAL	AB	RLD	2014-03-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205437-002	OTEZLA	20MG	TABLET / ORAL	AB	RLD	2014-03-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205437-003	OTEZLA	30MG	TABLET / ORAL	AB	RLD, RS	2014-03-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205437-001	OTEZLA	10MG	TABLET / ORAL	AB	RLD	2014-03-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205437-002	OTEZLA	20MG	TABLET / ORAL	AB	RLD	2014-03-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205437-003	OTEZLA	30MG	TABLET / ORAL	AB	RLD, RS	2014-03-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205437-001	OTEZLA	10MG	TABLET / ORAL		RLD	2014-03-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205437-002	OTEZLA	20MG	TABLET / ORAL		RLD	2014-03-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205437-003	OTEZLA	30MG	TABLET / ORAL		RLD, RS	2014-03-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205437-001	OTEZLA	10MG	TABLET / ORAL	AB	RLD	2014-03-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205437-002	OTEZLA	20MG	TABLET / ORAL	AB	RLD	2014-03-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205437-003	OTEZLA	30MG	TABLET / ORAL	AB	RLD, RS	2014-03-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205437-001	OTEZLA	10MG	TABLET / ORAL	AB	RLD	2014-03-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205437-002	OTEZLA	20MG	TABLET / ORAL	AB	RLD	2014-03-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205437-003	OTEZLA	30MG	TABLET / ORAL	AB	RLD, RS	2014-03-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205437-001	OTEZLA	10MG	TABLET / ORAL	AB	RLD	2014-03-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205437-002	OTEZLA	20MG	TABLET / ORAL	AB	RLD	2014-03-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205437-003	OTEZLA	30MG	TABLET / ORAL	AB	RLD, RS	2014-03-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205437-001	OTEZLA	10MG	TABLET / ORAL		RLD	2014-03-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205437-002	OTEZLA	20MG	TABLET / ORAL		RLD	2014-03-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205437-003	OTEZLA	30MG	TABLET / ORAL		RLD, RS	2014-03-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205437-001	OTEZLA	10MG	TABLET / ORAL		RLD	2014-03-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205437-002	OTEZLA	20MG	TABLET / ORAL		RLD	2014-03-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205437-003	OTEZLA	30MG	TABLET / ORAL		RLD, RS	2014-03-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205437-001	OTEZLA	10MG	TABLET / ORAL		RLD	2014-03-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205437-002	OTEZLA	20MG	TABLET / ORAL		RLD	2014-03-21	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N205437-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N205437-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205437-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205437-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205437-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205437-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205437-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205437-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205437-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205437-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205437-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205437-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205437-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205437-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205437-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205437-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205437-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205437-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205437-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205437-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205437-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205437-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205437-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205437-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205437-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205437-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205437-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205437-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205437-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205437-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205437-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205437-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205437-001	AB	1	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 1 of 64 · 2,544 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N205437-001	7427638	2028-02-16		Drug substance, Drug product	2014-04-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	7427638*PED	2028-08-16		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	12576034	2033-11-30	U-4291	Drug product	2026-04-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	12576034	2033-11-30	U-1858	Drug product	2026-04-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	12576034	2033-11-30	U-4290	Drug product	2026-04-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	10092541	2034-05-29	U-2403		2018-10-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	10092541	2034-05-29	U-2659		2018-10-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	9872854	2034-05-29	U-2232		2018-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	9872854	2034-05-29	U-2233		2018-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	12576034*PED	2034-05-30		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	10092541*PED	2034-11-29		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	9872854*PED	2034-11-29		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	7427638	2028-02-16		Drug substance, Drug product	2014-04-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	7427638*PED	2028-08-16		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	12576034	2033-11-30	U-4291	Drug product	2026-04-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	12576034	2033-11-30	U-1858	Drug product	2026-04-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	12576034	2033-11-30	U-4290	Drug product	2026-04-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	10092541	2034-05-29	U-2659		2018-10-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	10092541	2034-05-29	U-2403		2018-10-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	9872854	2034-05-29	U-2232		2018-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	9872854	2034-05-29	U-2233		2018-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	12576034*PED	2034-05-30		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	10092541*PED	2034-11-29		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	9872854*PED	2034-11-29		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	7427638	2028-02-16		Drug substance, Drug product	2014-04-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	7427638*PED	2028-08-16		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	12576034	2033-11-30	U-4291	Drug product	2026-04-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	12576034	2033-11-30	U-1858	Drug product	2026-04-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	12576034	2033-11-30	U-4290	Drug product	2026-04-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	10092541	2034-05-29	U-2403		2018-10-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	10092541	2034-05-29	U-2659		2018-10-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	9872854	2034-05-29	U-2232		2018-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	9872854	2034-05-29	U-2233		2018-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	12576034*PED	2034-05-30		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	10092541*PED	2034-11-29		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	9872854*PED	2034-11-29		Pediatric extension		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N205437-001	7427638	2028-02-16		Drug substance, Drug product	2014-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-001	7427638*PED	2028-08-16		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-001	12576034	2033-11-30	U-4291	Drug product	2026-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-001	12576034	2033-11-30	U-1858	Drug product	2026-04-16	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 16 · 603 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N205437-001	ODE-248	2026-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	M-299	2026-07-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	PED	2027-01-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	PED	2027-01-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	NPP	2027-04-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-001	PED	2027-10-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	ODE-248	2026-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	M-299	2026-07-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	PED	2027-01-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	PED	2027-01-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	NPP	2027-04-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-002	PED	2027-10-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	ODE-248	2026-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	M-299	2026-07-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	PED	2027-01-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	PED	2027-01-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	NPP	2027-04-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205437-003	PED	2027-10-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N205437-001	ODE-248	2026-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-001	M-299	2026-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-001	PED	2027-01-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-001	PED	2027-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-001	NPP	2027-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-001	PED	2027-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-002	ODE-248	2026-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-002	M-299	2026-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-002	PED	2027-01-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-002	PED	2027-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-002	NPP	2027-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-002	PED	2027-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-003	ODE-248	2026-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-003	M-299	2026-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-003	PED	2027-01-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-003	PED	2027-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-003	NPP	2027-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205437-003	PED	2027-10-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205437-001	ODE-248	2026-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205437-001	M-299	2026-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205437-001	PED	2027-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205437-001	PED	2027-01-20	`caaa826d4ba7…`

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	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205437 application number: NDA205437 ndc (product): 55513-369 ndc (product): 55513-485 ndc (product): 55513-137

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55513-137	Otezla	apremilast	Amgen Inc	NDA	Current
55513-137	Otezla	apremilast	Amgen Inc	NDA	Current
55513-137	Otezla	apremilast	Amgen Inc	NDA	Current
55513-137	Otezla	apremilast	Amgen Inc	NDA	Current
55513-137	Otezla	apremilast	Amgen Inc	NDA	Current
55513-137	Otezla	apremilast	Amgen Inc	NDA	Current
55513-137	Otezla	apremilast	Amgen Inc	NDA	Current
55513-137	Otezla	apremilast	Amgen Inc	NDA	Current
55513-137	Otezla	apremilast	Amgen Inc	NDA	Current
55513-137	Otezla	apremilast	Amgen Inc	NDA	Current
55513-369	Otezla	apremilast	Amgen Inc	NDA	Current
55513-369	Otezla	apremilast	Amgen Inc	NDA	Current
55513-369	Otezla	apremilast	Amgen Inc	NDA	Current
55513-369	Otezla	apremilast	Amgen Inc	NDA	Current
55513-369	Otezla	apremilast	Amgen Inc	NDA	Current
55513-369	Otezla	apremilast	Amgen Inc	NDA	Current
55513-369	Otezla	apremilast	Amgen Inc	NDA	Current
55513-369	Otezla	apremilast	Amgen Inc	NDA	Current
55513-369	Otezla	apremilast	Amgen Inc	NDA	Current
55513-369	Otezla	apremilast	Amgen Inc	NDA	Current
55513-485	Otezla	apremilast	Amgen Inc	NDA	Current
55513-485	Otezla	apremilast	Amgen Inc	NDA	Current
55513-485	Otezla	apremilast	Amgen Inc	NDA	Current
55513-485	Otezla	apremilast	Amgen Inc	NDA	Current
55513-485	Otezla	apremilast	Amgen Inc	NDA	Current
55513-485	Otezla	apremilast	Amgen Inc	NDA	Current
55513-485	Otezla	apremilast	Amgen Inc	NDA	Current
55513-485	Otezla	apremilast	Amgen Inc	NDA	Current
55513-485	Otezla	apremilast	Amgen Inc	NDA	Current
55513-485	Otezla	apremilast	Amgen Inc	NDA	Current
59572-630	OTEZLA	apremilast	Celgene Corporation	NDA	Current
59572-630	OTEZLA	apremilast	Celgene Corporation	NDA	Current
59572-630	OTEZLA	apremilast	Celgene Corporation	NDA	Current
59572-630	OTEZLA	apremilast	Celgene Corporation	NDA	Current
59572-631	OTEZLA	apremilast	Celgene Corporation	NDA	Current
59572-631	OTEZLA	apremilast	Celgene Corporation	NDA	Current
59572-631	OTEZLA	apremilast	Celgene Corporation	NDA	Current
59572-631	OTEZLA	apremilast	Celgene Corporation	NDA	Current
59572-632	OTEZLA	apremilast	Celgene Corporation	NDA	Current
59572-632	OTEZLA	apremilast	Celgene Corporation	NDA	Current
59572-632	OTEZLA	apremilast	Celgene Corporation	NDA	Current
59572-632	OTEZLA	apremilast	Celgene Corporation	NDA	Current
70518-3155	Otezla	apremilast	REMEDYREPACK INC.	NDA	Current
70518-3155	Otezla	apremilast	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85116	SUPPL	2026-02-24
84619	SUPPL	2025-12-31
84597	SUPPL	2025-12-30
82933	SUPPL	2025-07-25
82921	SUPPL	2025-07-25
78281	SUPPL	2024-04-26
78273	SUPPL	2024-04-26
76671	SUPPL	2023-11-28
74853	SUPPL	2023-07-21
74843	SUPPL	2023-07-21
69734	SUPPL	2021-12-21
69730	SUPPL	2021-12-21
62553	SUPPL	2020-04-13
62551	SUPPL	2020-04-13
59392	SUPPL	2019-07-22
59381	SUPPL	2019-07-19
48897	SUPPL	2017-07-05
48875	SUPPL	2017-06-30
19648	SUPPL	2015-12-28
32678	SUPPL	2015-12-22
22990	ORIG	2014-04-17
40471	ORIG	2014-03-25
32677	ORIG	2014-03-25