Application 207947

Type: NDA
Sponsor: ACTELION PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	UPTRAVI	SELEXIPAG	TABLET;ORAL	0.2MG	Yes	No
002	UPTRAVI	SELEXIPAG	TABLET;ORAL	0.4MG	Yes	Yes
003	UPTRAVI	SELEXIPAG	TABLET;ORAL	0.6MG	Yes	No
004	UPTRAVI	SELEXIPAG	TABLET;ORAL	0.8MG	Yes	No
005	UPTRAVI	SELEXIPAG	TABLET;ORAL	1MG	Yes	No
006	UPTRAVI	SELEXIPAG	TABLET;ORAL	1.2MG	Yes	No
007	UPTRAVI	SELEXIPAG	TABLET;ORAL	1.4MG	Yes	No
008	UPTRAVI	SELEXIPAG	TABLET;ORAL	1.6MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207947-001	UPTRAVI	SELEXIPAG	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-002	UPTRAVI	SELEXIPAG	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21
N207947-003	UPTRAVI	SELEXIPAG	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-004	UPTRAVI	SELEXIPAG	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-005	UPTRAVI	SELEXIPAG	1MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-006	UPTRAVI	SELEXIPAG	1.2MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-007	UPTRAVI	SELEXIPAG	1.4MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-008	UPTRAVI	SELEXIPAG	1.6MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-010	UPTRAVI	SELEXIPAG	0.1MG	TABLET / ORAL		RLD	2026-05-23
N207947-011	UPTRAVI	SELEXIPAG	0.15MG	TABLET / ORAL		RLD	2026-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
N207947-001	AB
N207947-002	AB
N207947-003	AB
N207947-004	AB
N207947-005	AB
N207947-006	AB
N207947-007	AB
N207947-008	AB

Orange Book patents#

Current patent rows page 1 of 2 · 120 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207947-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-001	7205302*PED	2027-04-30		Pediatric extension
N207947-001	9173881	2029-08-12	U-1798		2016-01-19
N207947-001	9173881*PED	2030-02-12		Pediatric extension
N207947-001	9284280	2030-06-25	U-1831		2016-04-12
N207947-001	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-001	9284280*PED	2030-12-25		Pediatric extension
N207947-001	8791122*PED	2031-02-01		Pediatric extension
N207947-001	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-001	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-001	10821108*PED	2037-06-01		Pediatric extension
N207947-001	10828298*PED	2037-06-01		Pediatric extension
N207947-002	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-002	7205302*PED	2027-04-30		Pediatric extension
N207947-002	9173881	2029-08-12	U-1798		2016-01-19
N207947-002	9173881*PED	2030-02-12		Pediatric extension
N207947-002	9284280	2030-06-25	U-1831		2016-04-12
N207947-002	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-002	9284280*PED	2030-12-25		Pediatric extension
N207947-002	8791122*PED	2031-02-01		Pediatric extension
N207947-002	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-002	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-002	10821108*PED	2037-06-01		Pediatric extension
N207947-002	10828298*PED	2037-06-01		Pediatric extension
N207947-003	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-003	7205302*PED	2027-04-30		Pediatric extension
N207947-003	9173881	2029-08-12	U-1798		2016-01-19
N207947-003	9173881*PED	2030-02-12		Pediatric extension
N207947-003	9284280	2030-06-25	U-1831		2016-04-12
N207947-003	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-003	9284280*PED	2030-12-25		Pediatric extension
N207947-003	8791122*PED	2031-02-01		Pediatric extension
N207947-003	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-003	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-003	10821108*PED	2037-06-01		Pediatric extension
N207947-003	10828298*PED	2037-06-01		Pediatric extension
N207947-004	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-004	7205302*PED	2027-04-30		Pediatric extension
N207947-004	9173881	2029-08-12	U-1798		2016-01-19
N207947-004	9173881*PED	2030-02-12		Pediatric extension
N207947-004	9284280	2030-06-25	U-1831		2016-04-12
N207947-004	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-004	9284280*PED	2030-12-25		Pediatric extension
N207947-004	8791122*PED	2031-02-01		Pediatric extension
N207947-004	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-004	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-004	10821108*PED	2037-06-01		Pediatric extension
N207947-004	10828298*PED	2037-06-01		Pediatric extension
N207947-005	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-005	7205302*PED	2027-04-30		Pediatric extension
N207947-005	9173881	2029-08-12	U-1798		2016-01-19
N207947-005	9173881*PED	2030-02-12		Pediatric extension
N207947-005	9284280	2030-06-25	U-1831		2016-04-12
N207947-005	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-005	9284280*PED	2030-12-25		Pediatric extension
N207947-005	8791122*PED	2031-02-01		Pediatric extension
N207947-005	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-005	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-005	10821108*PED	2037-06-01		Pediatric extension
N207947-005	10828298*PED	2037-06-01		Pediatric extension
N207947-006	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-006	7205302*PED	2027-04-30		Pediatric extension
N207947-006	9173881	2029-08-12	U-1798		2016-01-19
N207947-006	9173881*PED	2030-02-12		Pediatric extension
N207947-006	9284280	2030-06-25	U-1831		2016-04-12
N207947-006	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-006	9284280*PED	2030-12-25		Pediatric extension
N207947-006	8791122*PED	2031-02-01		Pediatric extension
N207947-006	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-006	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-006	10821108*PED	2037-06-01		Pediatric extension
N207947-006	10828298*PED	2037-06-01		Pediatric extension
N207947-007	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-007	7205302*PED	2027-04-30		Pediatric extension
N207947-007	9173881	2029-08-12	U-1798		2016-01-19
N207947-007	9173881*PED	2030-02-12		Pediatric extension
N207947-007	9284280	2030-06-25	U-1831		2016-04-12
N207947-007	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-007	9284280*PED	2030-12-25		Pediatric extension
N207947-007	8791122*PED	2031-02-01		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 20 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N207947-001	NPP	2029-05-23
N207947-001	PED	2029-11-23
N207947-002	NPP	2029-05-23
N207947-002	PED	2029-11-23
N207947-003	NPP	2029-05-23
N207947-003	PED	2029-11-23
N207947-004	NPP	2029-05-23
N207947-004	PED	2029-11-23
N207947-005	NPP	2029-05-23
N207947-005	PED	2029-11-23
N207947-006	NPP	2029-05-23
N207947-006	PED	2029-11-23
N207947-007	NPP	2029-05-23
N207947-007	PED	2029-11-23
N207947-008	NPP	2029-05-23
N207947-008	PED	2029-11-23
N207947-010	NS	2029-05-23
N207947-010	PED	2029-11-23
N207947-011	NS	2029-05-23
N207947-011	PED	2029-11-23

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 9 · 340 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
2026-08-18 06:07:40	2026-07	N207947-001	UPTRAVI	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	UPTRAVI	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	UPTRAVI	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	UPTRAVI	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-005	UPTRAVI	1MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-006	UPTRAVI	1.2MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-007	UPTRAVI	1.4MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-008	UPTRAVI	1.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-010	UPTRAVI	0.1MG	TABLET / ORAL		RLD	2026-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-011	UPTRAVI	0.15MG	TABLET / ORAL		RLD	2026-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207947-001	UPTRAVI	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-002	UPTRAVI	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-003	UPTRAVI	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-004	UPTRAVI	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-005	UPTRAVI	1MG	TABLET / ORAL		RLD	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-006	UPTRAVI	1.2MG	TABLET / ORAL		RLD	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-007	UPTRAVI	1.4MG	TABLET / ORAL	AB	RLD	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-008	UPTRAVI	1.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-001	UPTRAVI	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-002	UPTRAVI	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-003	UPTRAVI	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-004	UPTRAVI	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-005	UPTRAVI	1MG	TABLET / ORAL		RLD	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-006	UPTRAVI	1.2MG	TABLET / ORAL		RLD	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-007	UPTRAVI	1.4MG	TABLET / ORAL	AB	RLD	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-008	UPTRAVI	1.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207947-001	UPTRAVI	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-002	UPTRAVI	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-003	UPTRAVI	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-004	UPTRAVI	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-005	UPTRAVI	1MG	TABLET / ORAL		RLD	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-006	UPTRAVI	1.2MG	TABLET / ORAL		RLD	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-007	UPTRAVI	1.4MG	TABLET / ORAL	AB	RLD	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-008	UPTRAVI	1.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-001	UPTRAVI	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-002	UPTRAVI	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-003	UPTRAVI	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-004	UPTRAVI	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-005	UPTRAVI	1MG	TABLET / ORAL		RLD	2015-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-006	UPTRAVI	1.2MG	TABLET / ORAL		RLD	2015-12-21	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 146 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N207947-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207947-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207947-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207947-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207947-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207947-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207947-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207947-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207947-008	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207947-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207947-002	AB	1	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 54 · 2,128 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	N207947-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	7205302*PED	2027-04-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	9173881	2029-08-12	U-1798		2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	9173881*PED	2030-02-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	9284280	2030-06-25	U-1831		2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	8791122	2030-08-01		Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	9284280*PED	2030-12-25		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	8791122*PED	2031-02-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	10821108	2036-12-01	U-2992	Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	10828298	2036-12-01	U-2991	Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	10821108*PED	2037-06-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	10828298*PED	2037-06-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	7205302*PED	2027-04-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	9173881	2029-08-12	U-1798		2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	9173881*PED	2030-02-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	9284280	2030-06-25	U-1831		2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	8791122	2030-08-01		Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	9284280*PED	2030-12-25		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	8791122*PED	2031-02-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	10821108	2036-12-01	U-2992	Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	10828298	2036-12-01	U-2991	Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	10821108*PED	2037-06-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	10828298*PED	2037-06-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	7205302*PED	2027-04-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	9173881	2029-08-12	U-1798		2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	9173881*PED	2030-02-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	9284280	2030-06-25	U-1831		2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	8791122	2030-08-01		Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	9284280*PED	2030-12-25		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	8791122*PED	2031-02-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	10821108	2036-12-01	U-2992	Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	10828298	2036-12-01	U-2991	Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	10821108*PED	2037-06-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	10828298*PED	2037-06-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	7205302*PED	2027-04-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	9173881	2029-08-12	U-1798		2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	9173881*PED	2030-02-12		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 232 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	N207947-001	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-005	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-005	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-006	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-006	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-007	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-007	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-008	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-008	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-010	NS	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-010	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-011	NS	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-011	PED	2029-11-23	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-001	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-002	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-003	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-004	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-005	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-006	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-007	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-008	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207947-001	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-002	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-003	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-004	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-005	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-006	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-007	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-008	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207947-001	ODE-106	2022-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207947-002	ODE-106	2022-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207947-003	ODE-106	2022-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207947-004	ODE-106	2022-12-21	`4b0b4de00fa7…`

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
UPTRAVI	SELEXIPAG	Actelion Pharmaceuticals US, Inc.	a7a23b87-f892-4e2c-8e2e-ebf841220f90	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207947 application number: NDA207947 ndc (product): 66215-612 ndc (product): 66215-614 ndc (product): 66215-606 ndc (product): 66215-616 ndc (product): 66215-608 ndc (product): 66215-604 ndc (product): 66215-602 ndc (product): 66215-610

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 101 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-602	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-604	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-606	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-608	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-610	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-612	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-614	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-616	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-616	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-616	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69121	SUPPL	2021-10-26
69114	SUPPL	2021-10-26
68447	SUPPL	2021-08-24
68426	SUPPL	2021-08-20
66048	SUPPL	2021-02-01
66041	SUPPL	2021-02-01
59920	SUPPL	2019-09-05
59914	SUPPL	2019-09-05
50906	SUPPL	2017-12-27
50845	SUPPL	2017-12-22
49895	SUPPL	2017-09-29
49881	SUPPL	2017-09-29
49078	SUPPL	2017-07-25
49054	SUPPL	2017-07-25
24529	ORIG	2016-01-28
23043	ORIG	2016-01-28
32866	ORIG	2015-12-22
19976	ORIG	2015-12-22