Application 216187

Type: ANDA
Sponsor: CHANGZHOU PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TICAGRELOR	TICAGRELOR	TABLET;ORAL	60MG	No	No
002	TICAGRELOR	TICAGRELOR	TABLET;ORAL	90MG	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
A216187-001	TICAGRELOR	TICAGRELOR	60MG	TABLET / ORAL	AB		2025-10-28
A216187-002	TICAGRELOR	TICAGRELOR	90MG	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
A216187-001	AB
A216187-002	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.

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
2026-08-01 22:54:32	2026-06	A216187-001	TICAGRELOR	60MG	TABLET / ORAL	AB		2025-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A216187-002	TICAGRELOR	90MG	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
2026-08-01 22:54:32	2026-06	A216187-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A216187-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ticagrelor	TICAGRELOR	Changzhou Pharmaceutical Factory	751410c1-452b-400b-a640-d31623a6fda3	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216187 application number: ANDA216187
Ticagrelor	TICAGRELOR	BIONPHARMA INC.	4239fc4c-dae6-eb51-e063-6394a90a00d5	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216187 application number: ANDA216187