Application 214275

Type: NDA
Sponsor: ACTELION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	UPTRAVI	SELEXIPAG	TABLET;ORAL	200MCG	No	No
002	UPTRAVI	SELEXIPAG	TABLET;ORAL	400MCG	No	No
003	UPTRAVI	SELEXIPAG	TABLET;ORAL	600MCG	No	No
004	UPTRAVI	SELEXIPAG	TABLET;ORAL	800MCG	No	No
005	UPTRAVI	SELEXIPAG	TABLET;ORAL	1000MCG	No	No
006	UPTRAVI	SELEXIPAG	TABLET;ORAL	1200MCG	No	No
007	UPTRAVI	SELEXIPAG	TABLET;ORAL	1400MCG	No	No
008	UPTRAVI	SELEXIPAG	TABLET;ORAL	1600MCG	No	No
009	UPTRAVI	SELEXIPAG	INJECTABLE;INJECTION	1800MCG	No	No

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

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
N214275-001	UPTRAVI	SELEXIPAG	1.8MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2021-07-29

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214275-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2021-08-27
N214275-001	7205302*PED	2027-04-30		Pediatric extension
N214275-001	9173881	2029-08-12	U-1798		2021-08-27
N214275-001	9173881*PED	2030-02-12		Pediatric extension
N214275-001	9284280	2030-06-25	U-1831		2021-08-27
N214275-001	8791122	2030-08-01		Drug substance, Drug product	2021-08-27
N214275-001	9284280*PED	2030-12-25		Pediatric extension
N214275-001	8791122*PED	2031-02-01		Pediatric extension

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
2026-08-18 06:07:40	2026-07	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214275-001	UPTRAVI	1.8MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-07-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 148 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	N214275-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2021-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214275-001	7205302*PED	2027-04-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214275-001	9173881	2029-08-12	U-1798		2021-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214275-001	9173881*PED	2030-02-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214275-001	9284280	2030-06-25	U-1831		2021-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214275-001	8791122	2030-08-01		Drug substance, Drug product	2021-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214275-001	9284280*PED	2030-12-25		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214275-001	8791122*PED	2031-02-01		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214275-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214275-001	7205302*PED	2027-04-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214275-001	9173881	2029-08-12	U-1798		2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214275-001	9173881*PED	2030-02-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214275-001	9284280	2030-06-25	U-1831		2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214275-001	8791122	2030-08-01		Drug substance, Drug product	2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214275-001	9284280*PED	2030-12-25		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214275-001	8791122*PED	2031-02-01		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214275-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2021-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214275-001	9173881	2029-08-12	U-1798		2021-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214275-001	9284280	2030-06-25	U-1831		2021-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214275-001	8791122	2030-08-01		Drug substance, Drug product	2021-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214275-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2021-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214275-001	9173881	2029-08-12	U-1798		2021-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214275-001	9284280	2030-06-25	U-1831		2021-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214275-001	8791122	2030-08-01		Drug substance, Drug product	2021-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214275-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2021-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214275-001	9173881	2029-08-12	U-1798		2021-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214275-001	9284280	2030-06-25	U-1831		2021-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214275-001	8791122	2030-08-01		Drug substance, Drug product	2021-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214275-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2021-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214275-001	9173881	2029-08-12	U-1798		2021-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214275-001	9284280	2030-06-25	U-1831		2021-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214275-001	8791122	2030-08-01		Drug substance, Drug product	2021-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214275-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2021-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214275-001	9173881	2029-08-12	U-1798		2021-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214275-001	9284280	2030-06-25	U-1831		2021-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214275-001	8791122	2030-08-01		Drug substance, Drug product	2021-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214275-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2021-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214275-001	9173881	2029-08-12	U-1798		2021-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214275-001	9284280	2030-06-25	U-1831		2021-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214275-001	8791122	2030-08-01		Drug substance, Drug product	2021-08-27	`2680178bc6a6…`

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): 214275 application number: NDA214275 ndc (product): 66215-718

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66215-718	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-718	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-718	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-718	UPTRAVI	Selexipag	Actelion Pharmaceuticals US, Inc.	NDA	Current
82595-000	UPTRAVI	SELEXIPAG	EUROFINS AMATSIGROUP SAS	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69131	ORIG	2021-10-27
68260	ORIG	2021-08-02
68248	ORIG	2021-08-02