Application 208531

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TICAGRELOR	TICAGRELOR	TABLET;ORAL	90MG	No	No
002	TICAGRELOR	TICAGRELOR	TABLET;ORAL	60MG	No	No

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

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
A208531-001	TICAGRELOR	TICAGRELOR	90MG	TABLET / ORAL			2019-01-23
A208531-002	TICAGRELOR	TICAGRELOR	60MG	TABLET / ORAL			2025-10-28

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 2 · 46 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
2026-08-18 06:07:40	2026-07	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208531-002	TICAGRELOR	60MG	TABLET / ORAL		2025-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208531-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208531-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208531-001	TICAGRELOR	90MG	TABLET / ORAL		2019-01-23	`3bdfa0b2c4d7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208531-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208531-002	AB	1	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208531-001	PC	2025-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208531-001	PC	2025-10-28	`6a471c1ec25d…`

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ticagrelor	TICAGRELOR	Hisun Pharmaceuticals USA, Inc.	c4c1ca82-99bd-451a-ad77-7fe28c4ae3e8	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR
Ticagrelor	TICAGRELOR	AiPing Pharmaceutical, Inc	4ecb82df-fad2-1f6c-e063-6294a90a9d19	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR
Ticagrelor	TICAGRELOR	Redpharm Drug	557351f1-47b7-216d-e063-6394a90afb51	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR
Ticagrelor	TICAGRELOR	Golden State Medical Supply, Inc.	37f1d3d7-030f-180a-e063-6294a90a89da	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR
Ticagrelor	TICAGRELOR	Macleods Pharmaceuticals Limited	32769721-c1dd-4bd3-90aa-a6cab59d3cd6	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR
Ticagrelor	TICAGRELOR	NorthStar RxLLC	c89c29c9-d2c0-4605-b74f-059e0b104977	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR
Ticagrelor	TICAGRELOR	Apotex Corp.	2c59ea45-6113-6e9e-70b5-3b8c8b3d89b6	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR
Ticagrelor	TICAGRELOR	Dr. Reddys Laboratories Inc	1225fd45-9b56-1671-ee77-cd0c9f2174a5	2026-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR
Ticagrelor	TICAGRELOR	Lifestar Pharma LLC	7efe86fa-5d19-413a-8b15-e51279b62f3f	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR
Ticagrelor	TICAGRELOR	Ascend Laboratories, LLC	2f73a4db-2c7f-4e42-a914-87aedc2780fb	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR
BRILINTA	TICAGRELOR	AstraZeneca Pharmaceuticals LP	f7b3f443-e83d-4bf2-0e96-023448fed9a8	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TICAGRELOR
BRILINTA	TICAGRELOR	Cardinal Health 107, LLC	4f9bd52a-99a7-4606-92b4-456a917aabef	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TICAGRELOR
TICAGRELOR	TICAGRELOR	Novadoz Pharmaceuticals LLC	b1c29d47-960f-4fc4-b6ff-399e2c6eec4c	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TICAGRELOR generic name: TICAGRELOR
TICAGRELOR	TICAGRELOR	Aphena Pharma Solutions - Tennessee, LLC	37b2d081-c17a-c126-e063-6394a90a5729	2026-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TICAGRELOR generic name: TICAGRELOR
Ticagrelor	TICAGRELOR	American Health Packaging	a50eb0b4-1bee-4781-8eba-75e324540d36	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR
ticagrelor	TICAGRELOR	ScieGen Pharmaceuticals INC	40ac26dc-2570-de7e-e063-6294a90ade72	2025-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ticagrelor generic name: TICAGRELOR
Ticagrelor	TICAGRELOR	Aphena Pharma Solutions - Tennessee, LLC	41c5d35c-91de-a8a4-e063-6394a90ac5ff	2025-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR
ticagrelor	TICAGRELOR	Radha Pharmaceuticals INC	436d1bef-da01-7d0a-e063-6294a90abd90	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ticagrelor generic name: TICAGRELOR
TICAGRELOR	TICAGRELOR	Solco Healthcare U.S., LLC	5be5ef20-fc9f-4c3b-a482-83ffd8a3ab47	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TICAGRELOR generic name: TICAGRELOR
Ticagrelor	TICAGRELOR	Alembic Pharmaceuticals Inc.	d68b79ab-3104-410e-a63f-9919a23625af	2025-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ticagrelor generic name: TICAGRELOR

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69238-1134	ticagrelor	ticagrelor	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1134	ticagrelor	ticagrelor	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1134	ticagrelor	ticagrelor	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1134	Ticagrelor	Ticagrelor	Amneal Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57716	ORIG	2019-02-21