Application 208596

Type: ANDA
Sponsor: SIGMAPHARM LABS LLC

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 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
A208596-001	TICAGRELOR	TICAGRELOR	90MG	TABLET / ORAL	AB		2020-04-07
A208596-002	TICAGRELOR	TICAGRELOR	60MG	TABLET / ORAL	AB		2025-10-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A208596-001	AB
A208596-002	AB

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	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208596-001	TICAGRELOR	90MG	TABLET / ORAL		2020-04-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208596-001	TICAGRELOR	90MG	TABLET / ORAL	AB	2020-04-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208596-002	TICAGRELOR	60MG	TABLET / ORAL	AB	2025-10-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208596-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208596-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208596-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208596-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208596-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208596-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208596-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208596-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208596-001	AB	1	`6a471c1ec25d…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208596-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208596-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208596-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208596-001	AB	1	`c0c555d07b60…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208596-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208596-002	AB	1	`a50c72e98297…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TICAGRELOR	TICAGRELOR	Aphena Pharma Solutions - Tennessee, LLC	5955a5f5-fbc7-8f67-e063-6394a90ada36	2026-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208596 application number: ANDA208596
TICAGRELOR	TICAGRELOR	Novadoz Pharmaceuticals LLC	b1c29d47-960f-4fc4-b6ff-399e2c6eec4c	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208596 application number: ANDA208596
TICAGRELOR	TICAGRELOR	AvPAK	425024ab-e092-7a6d-e063-6294a90ae4f3	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208596 application number: ANDA208596
TICAGRELOR	TICAGRELOR	AvKARE	40bb0fb0-2275-4df7-e063-6394a90ade2e	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208596 application number: ANDA208596
TICAGRELOR	TICAGRELOR	AvKARE	32ebf046-73e4-b11b-e063-6294a90a5bf4	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208596 application number: ANDA208596

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.