Application 214442

Type: ANDA
Sponsor: CHANGZHOU PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	12.5MG	No	No
002	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	25MG	No	No
003	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	50MG	No	No
004	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	100MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214442-001	CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2023-01-27
A214442-002	CAPTOPRIL	CAPTOPRIL	25MG	TABLET / ORAL	AB	2023-01-27
A214442-003	CAPTOPRIL	CAPTOPRIL	50MG	TABLET / ORAL	AB	2023-01-27
A214442-004	CAPTOPRIL	CAPTOPRIL	100MG	TABLET / ORAL	AB	2023-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A214442-001	AB
A214442-002	AB
A214442-003	AB
A214442-004	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	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A214442-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2023-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214442-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2023-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214442-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2023-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214442-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2023-01-27	`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	A214442-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214442-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214442-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214442-004	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Captopril	CAPTOPRIL	AiPing Pharmaceutical, Inc.	3b789f16-b291-4012-be39-af3beec3ff9a	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214442 application number: ANDA214442