Application 209509

Type: ANDA
Sponsor: PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMBRISENTAN	AMBRISENTAN	TABLET;ORAL	5MG	No	No
002	AMBRISENTAN	AMBRISENTAN	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209509-001	AMBRISENTAN	AMBRISENTAN	5MG	TABLET / ORAL			2019-04-10
A209509-002	AMBRISENTAN	AMBRISENTAN	10MG	TABLET / ORAL			2019-04-10

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL		2019-04-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL		2019-04-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-04-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-04-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-04-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-04-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-04-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-04-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209509-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-04-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209509-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-04-10	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A209509-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209509-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209509-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209509-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209509-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209509-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209509-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A209509-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209509-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A209509-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209509-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209509-002	AB	1	`cb3db0bc1861…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ambrisentan	AMBRISENTAN	Apotex Corp.	291a782a-77e1-8a8e-e1c8-2626f305c2b7	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ambrisentan generic name: AMBRISENTAN
Ambrisentan	AMBRISENTAN	Zydus Pharmaceuticals USA Inc.	37af3191-0ed3-4783-8747-065f1462f2d2	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ambrisentan generic name: AMBRISENTAN
Letairis	AMBRISENTAN	Gilead Sciences, Inc.	725d4e73-6c83-477a-adc6-0ae4a133a844	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMBRISENTAN
Ambrisentan	AMBRISENTAN	Golden State Medical Supply, Inc.	4396bab5-2851-62ef-e063-6294a90af76e	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ambrisentan generic name: AMBRISENTAN
Ambrisentan	AMBRISENTAN	Quallent Pharmaceuticals Health LLC	6fc6032f-94dc-4067-8b24-01990ec99db0	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ambrisentan generic name: AMBRISENTAN
Ambrisentan	AMBRISENTAN	Mylan Pharmaceuticals Inc.	8080b009-361b-4505-b09a-0d91a0e4a2c0	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ambrisentan generic name: AMBRISENTAN
ambrisentan	AMBRISENTAN	A-S Medication Solutions	a7dcdea4-d3da-4dc1-9193-6ebdb5b4e690	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ambrisentan generic name: AMBRISENTAN
ambrisentan	AMBRISENTAN	A-S Medication Solutions	fda3e8b5-267b-4690-85c2-78626986245c	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ambrisentan generic name: AMBRISENTAN
Ambrisentan	AMBRISENTAN	Actavis Pharma, Inc.	32549c43-f8ff-422c-b42d-ca0877e661cf	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ambrisentan generic name: AMBRISENTAN
ambrisentan	AMBRISENTAN	Sun Pharmaceutical Industries, Inc.	a4978a54-1799-43d6-85dd-05fa9de0a5d7	2025-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ambrisentan generic name: AMBRISENTAN
Ambrisentan	AMBRISENTAN	Cipla USA Inc.	0e418384-cae1-47ae-ac5e-afc845d694f6	2025-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ambrisentan generic name: AMBRISENTAN
ambrisentan	AMBRISENTAN	Aurobindo Pharma Limited	82e51c75-fb78-4ad3-8bce-5e0581d60014	2025-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ambrisentan generic name: AMBRISENTAN
Ambrisentan	AMBRISENTAN	Zydus Lifesciences Limited	0e3e3320-27ac-404f-9f01-3d82696e768a	2024-11-25		Name fallback brand name: Ambrisentan generic name: AMBRISENTAN
AMBRISENTAN	AMBRISENTAN	Sigmapharm Laboratories, LLC	e20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac	2023-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: AMBRISENTAN generic name: AMBRISENTAN

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-353	Ambrisentan	Ambrisentan	Par Pharmaceutical, Inc.	ANDA	Current
49884-353	Ambrisentan	Ambrisentan	Par Pharmaceutical, Inc.	ANDA	Current
49884-353	Ambrisentan	Ambrisentan	Par Pharmaceutical, Inc.	ANDA	Current
49884-354	Ambrisentan	Ambrisentan	Par Pharmaceutical, Inc.	ANDA	Current
49884-354	Ambrisentan	Ambrisentan	Par Pharmaceutical, Inc.	ANDA	Current
49884-354	Ambrisentan	Ambrisentan	Par Pharmaceutical, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76414	ORIG	2023-11-06