Application 206002

Type: ANDA
Sponsor: ALVOGEN PINE BROOK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BOSENTAN	BOSENTAN	TABLET;ORAL	62.5MG	No	No
002	BOSENTAN	BOSENTAN	TABLET;ORAL	125MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206002-001	BOSENTAN	BOSENTAN	62.5MG	TABLET / ORAL			2019-04-26
A206002-002	BOSENTAN	BOSENTAN	125MG	TABLET / ORAL			2019-04-26

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206002-001	BOSENTAN	62.5MG	TABLET / ORAL	2019-04-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206002-002	BOSENTAN	125MG	TABLET / ORAL	2019-04-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A206002-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206002-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206002-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206002-002	AB	1	`ea99ee380514…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bosentan	BOSENTAN	Zydus Pharmaceuticals USA Inc.	8444da17-6c31-492b-8842-93740f083d9d	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bosentan generic name: BOSENTAN
bosentan	BOSENTAN	Zydus Lifesciences Limited	b88cc559-93ae-42db-9c38-fb5e9c4802e6	2026-02-14		Name fallback brand name: bosentan generic name: BOSENTAN
Bosentan	BOSENTAN	Sun Pharmaceutical Industries, Inc.	c006d8ef-8cb7-4fb3-88eb-b2debc302a20	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bosentan generic name: BOSENTAN
bosentan	BOSENTAN	Actavis Pharma, Inc.	39b2a85f-4322-42d4-b420-1b1d52569143	2025-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bosentan generic name: BOSENTAN
Tracleer	BOSENTAN	Actelion Pharmaceuticals US, Inc.	749e42fb-2fe0-45dd-9268-b43bb3f4081c	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BOSENTAN
bosentan	BOSENTAN	Zydus Pharmaceuticals USA Inc.	c1e75179-cbea-4535-8709-f6d79c1d4004	2025-11-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bosentan generic name: BOSENTAN
Bosentan	BOSENTAN	Lupin Pharmaceuticals, Inc.	540b6f6a-79f3-4681-8c2a-268cf7cecbc9	2025-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bosentan generic name: BOSENTAN
Bosentan	BOSENTAN	Zydus Lifesciences Limited	02892f47-0d59-4254-9ee7-d524278fdd79	2024-11-25		Name fallback brand name: Bosentan generic name: BOSENTAN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-270	Bosentan	Bosentan	Alvogen Inc.	ANDA	Current
47781-270	Bosentan	Bosentan	Alvogen Inc.	ANDA	Current
47781-270	Bosentan	Bosentan	Alvogen Inc.	ANDA	Current
47781-270	Bosentan	Bosentan	Alvogen Inc.	ANDA	Current
47781-271	Bosentan	Bosentan	Alvogen Inc.	ANDA	Current
47781-271	Bosentan	Bosentan	Alvogen Inc.	ANDA	Current
47781-271	Bosentan	Bosentan	Alvogen Inc.	ANDA	Current
47781-271	Bosentan	Bosentan	Alvogen Inc.	ANDA	Current