Application 074677

Type: ANDA
Sponsor: BOSCOGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	50MG	No	No
002	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	25MG	No	No
003	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	100MG	No	No
004	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	12.5MG	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
A074677-001	CAPTOPRIL	CAPTOPRIL	50MG	TABLET / ORAL	AB	1997-05-30
A074677-002	CAPTOPRIL	CAPTOPRIL	25MG	TABLET / ORAL	AB	1997-05-30
A074677-003	CAPTOPRIL	CAPTOPRIL	100MG	TABLET / ORAL	AB	1997-05-30
A074677-004	CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1997-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074677-001	AB
A074677-002	AB
A074677-003	AB
A074677-004	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.

Product history page 1 of 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A074677-001	CAPTOPRIL	50MG	TABLET / ORAL	AB	1997-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074677-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1997-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074677-003	CAPTOPRIL	100MG	TABLET / ORAL	AB	1997-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074677-004	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1997-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074677-001	CAPTOPRIL	50MG	TABLET / ORAL	AB	1997-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074677-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1997-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074677-003	CAPTOPRIL	100MG	TABLET / ORAL	AB	1997-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074677-004	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1997-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074677-001	CAPTOPRIL	50MG	TABLET / ORAL	AB	1997-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074677-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1997-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074677-003	CAPTOPRIL	100MG	TABLET / ORAL	AB	1997-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074677-004	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1997-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074677-001	CAPTOPRIL	50MG	TABLET / ORAL	AB	1997-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074677-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1997-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074677-003	CAPTOPRIL	100MG	TABLET / ORAL	AB	1997-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074677-004	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1997-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074677-001	CAPTOPRIL	50MG	TABLET / ORAL	AB	1997-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074677-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1997-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074677-003	CAPTOPRIL	100MG	TABLET / ORAL	AB	1997-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074677-004	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1997-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074677-001	CAPTOPRIL	50MG	TABLET / ORAL	AB	1997-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074677-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1997-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074677-003	CAPTOPRIL	100MG	TABLET / ORAL	AB	1997-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074677-004	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1997-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074677-001	CAPTOPRIL	50MG	TABLET / ORAL	AB	1997-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074677-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1997-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074677-003	CAPTOPRIL	100MG	TABLET / ORAL	AB	1997-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074677-004	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1997-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074677-001	CAPTOPRIL	50MG	TABLET / ORAL	AB	1997-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074677-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1997-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074677-003	CAPTOPRIL	100MG	TABLET / ORAL	AB	1997-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074677-004	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1997-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074677-001	CAPTOPRIL	50MG	TABLET / ORAL	AB	1997-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074677-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1997-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074677-003	CAPTOPRIL	100MG	TABLET / ORAL	AB	1997-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074677-004	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1997-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074677-001	CAPTOPRIL	50MG	TABLET / ORAL	AB	1997-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074677-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1997-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074677-003	CAPTOPRIL	100MG	TABLET / ORAL	AB	1997-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074677-004	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1997-05-30	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074677-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074677-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074677-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074677-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074677-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074677-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074677-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074677-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074677-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074677-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074677-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074677-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074677-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074677-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074677-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074677-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074677-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074677-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074677-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074677-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074677-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074677-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074677-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074677-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074677-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074677-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074677-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074677-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074677-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074677-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074677-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074677-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074677-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074677-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074677-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074677-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074677-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074677-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074677-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074677-004	AB	1	`d06236e962d9…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
captopril	CAPTOPRIL	Method Pharmaceuticals LLC	1a91ac7f-b75d-d111-e063-6394a90a2a93	2025-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074677 application number: ANDA074677
captopril	CAPTOPRIL	Bryant Ranch Prepack	ccbffd30-4b21-4522-bdb8-abba8d592017	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074677 application number: ANDA074677
captopril	CAPTOPRIL	AMICI PHARMACEUTICALS LLC	1395ba5b-2fc9-41ff-9c43-e0740d781dee	2022-09-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074677 application number: ANDA074677 ndc (product): 69292-522 ndc (product): 69292-528 ndc (product): 69292-526 ndc (product): 69292-524

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5964	captopril	captopril	A-S Medication Solutions	ANDA	Current
50090-5964	captopril	captopril	A-S Medication Solutions	ANDA	Current
69292-522	captopril	captopril	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-522	captopril	captopril	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-522	captopril	captopril	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-524	captopril	captopril	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-524	captopril	captopril	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-524	captopril	captopril	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-526	captopril	captopril	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-526	captopril	captopril	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-526	captopril	captopril	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-528	captopril	captopril	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-528	captopril	captopril	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-528	captopril	captopril	AMICI PHARMACEUTICALS LLC	ANDA	Current