Application 209279

Type: NDA
Sponsor: ACTELION PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRACLEER	BOSENTAN	TABLET, FOR SUSPENSION;ORAL	32MG	Yes	Yes

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

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
N209279-001	TRACLEER	BOSENTAN	32MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2017-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N209279-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209279-001	8309126	2026-05-15		Drug product	2017-10-03
N209279-001	7959945	2027-12-28		Drug product	2017-10-03

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 2 · 44 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
2022-10-28 04:53 UTC	2022-10	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2017-09-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209279-001	TRACLEER	32MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2017-09-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N209279-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209279-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209279-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209279-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209279-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209279-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209279-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209279-001	AB	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209279-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209279-001	8309126	2026-05-15	Drug product	2017-10-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209279-001	7959945	2027-12-28	Drug product	2017-10-03	`4b0b4de00fa7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209279-001	ODE-161	2024-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209279-001	ODE-161	2024-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209279-001	ODE-161	2024-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209279-001	ODE-161	2024-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209279-001	ODE-161	2024-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209279-001	ODE-161	2024-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209279-001	ODE-161	2024-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209279-001	ODE-161	2024-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209279-001	ODE-161	2024-09-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209279-001	ODE-161	2024-09-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209279-001	ODE-161	2024-09-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209279-001	ODE-161	2024-09-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209279-001	NP	2020-09-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209279-001	ODE-161	2024-09-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209279-001	ODE-161	2024-09-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209279-001	ODE-161	2024-09-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209279-001	ODE-161	2024-09-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209279-001	ODE-161	2024-09-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209279-001	NP	2020-09-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209279-001	ODE-161	2024-09-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209279-001	NP	2020-09-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209279-001	ODE-161	2024-09-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209279-001	NP	2020-09-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209279-001	ODE-161	2024-09-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209279-001	NP	2020-09-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209279-001	ODE-161	2024-09-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209279-001	NP	2020-09-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209279-001	ODE-161	2024-09-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209279-001	ODE-161	2024-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209279-001	ODE-161	2024-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209279-001	ODE-161	2024-09-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209279-001	ODE-161	2024-09-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209279-001	ODE-161	2024-09-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209279-001	ODE-161	2024-09-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209279-001	ODE-161	2024-09-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209279-001	ODE-161	2024-09-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209279-001	ODE-161	2024-09-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209279-001	ODE-161	2024-09-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209279-001	ODE-161	2024-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209279-001	ODE-161	2024-09-05	`e64feba35796…`

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
Tracleer	BOSENTAN	Actelion Pharmaceuticals US, Inc.	749e42fb-2fe0-45dd-9268-b43bb3f4081c	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209279 application number: NDA209279 ndc (product): 66215-232

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66215-103	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-103	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-103	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-103	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-103	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-103	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-103	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-103	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-103	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-232	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-232	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-232	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current
66215-232	Tracleer	bosentan	Actelion Pharmaceuticals US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85269	SUPPL	2026-03-04
84135	SUPPL	2025-11-12
84136	SUPPL	2025-11-10
84084	SUPPL	2025-11-06
83013	SUPPL	2025-08-01
79654	SUPPL	2024-09-19
77458	SUPPL	2024-02-09
77430	SUPPL	2024-02-09
76401	ORIG	2023-11-06
72573	SUPPL	2022-11-07
72538	SUPPL	2022-11-02
70935	SUPPL	2022-05-03
58799	SUPPL	2019-05-20
58798	SUPPL	2019-05-20
58771	SUPPL	2019-05-17
58508	SUPPL	2019-05-01
58479	SUPPL	2019-04-30
56183	SUPPL	2018-10-30
56110	SUPPL	2018-10-26
55866	ORIG	2018-10-10
55865	SUPPL	2018-10-10
49667	ORIG	2018-06-25
50142	SUPPL	2017-12-29