Application 205670

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	TABLET;ORAL	10MG	No	No
002	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	TABLET;ORAL	20MG	No	No
003	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	TABLET;ORAL	40MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205670-001	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29
A205670-002	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29
A205670-003	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205670-001	AB
A205670-002	AB
A205670-003	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 4 · 126 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	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205670-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2016-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205670-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2016-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205670-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2016-08-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205670-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205670-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205670-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205670-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205670-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205670-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205670-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205670-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205670-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205670-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205670-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205670-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205670-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205670-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205670-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205670-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205670-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205670-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205670-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205670-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205670-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205670-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205670-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205670-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205670-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205670-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205670-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205670-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205670-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205670-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205670-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205670-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205670-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205670-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205670-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205670-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205670-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205670-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205670-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205670-001	AB	1	`1e350fbaab3a…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosinopril sodium	FOSINOPIRL SODIUM	Bryant Ranch Prepack	3d521d4d-29f8-40d7-971b-0efb68dfbff2	2023-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205670 application number: ANDA205670 ndc (product): 71335-0726
Fosinopril sodium	FOSINOPRIL SODIUM	A-S Medication Solutions	46e3e4e8-c611-4d4f-ad57-050b4c01fcd8	2023-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205670 application number: ANDA205670 ndc (product): 50090-4743
Fosinopril sodium	FOSINOPRIL SODIUM	Bryant Ranch Prepack	ee78de8e-22f4-4c3b-a721-e9464d704eda	2023-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205670 application number: ANDA205670
Fosinopril sodium	FOSINOPIRL SODIUM	Solco Healthcare LLC	0a66f606-5e6f-473d-8a1e-9ef316adb2e2	2021-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205670 application number: ANDA205670 ndc (product): 43547-388 ndc (product): 43547-387 ndc (product): 43547-386

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-386	Fosinopril sodium	fosinopirl sodium	Solco Healthcare LLC	ANDA	Current
43547-386	Fosinopril sodium	fosinopirl sodium	Solco Healthcare LLC	ANDA	Current
43547-387	Fosinopril sodium	fosinopril sodium	Solco Healthcare LLC	ANDA	Current
43547-387	Fosinopril sodium	fosinopril sodium	Solco Healthcare LLC	ANDA	Current
43547-388	Fosinopril sodium	fosinopril sodium	Solco Healthcare LLC	ANDA	Current
43547-388	Fosinopril sodium	fosinopril sodium	Solco Healthcare LLC	ANDA	Current
50090-3780	Fosinopril sodium	fosinopirl sodium	A-S Medication Solutions	ANDA	Current
50090-3780	Fosinopril sodium	fosinopirl sodium	A-S Medication Solutions	ANDA	Current
50090-4743	Fosinopril sodium	fosinopril sodium	A-S Medication Solutions	ANDA	Current
50090-4743	Fosinopril sodium	fosinopril sodium	A-S Medication Solutions	ANDA	Current
50268-327	Fosinopril sodium	fosinopirl sodium	AvPAK	ANDA	Current
50268-327	Fosinopril sodium	fosinopirl sodium	AvPAK	ANDA	Current
50268-328	Fosinopril sodium	fosinopril sodium	AvPAK	ANDA	Current
50268-328	Fosinopril sodium	fosinopril sodium	AvPAK	ANDA	Current
50268-329	Fosinopril sodium	fosinopril sodium	AvPAK	ANDA	Current
50268-329	Fosinopril sodium	fosinopril sodium	AvPAK	ANDA	Current
68788-7333	Fosinopril sodium	fosinopril sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7333	Fosinopril sodium	fosinopril sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
70934-632	Fosinopril sodium	fosinopril sodium	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71335-0726	Fosinopril sodium	fosinopirl sodium	Bryant Ranch Prepack	ANDA	Current
71335-0726	Fosinopril sodium	fosinopirl sodium	Bryant Ranch Prepack	ANDA	Current
71335-0726	Fosinopril sodium	fosinopirl sodium	Bryant Ranch Prepack	ANDA	Current
71335-1115	Fosinopril sodium	fosinopril sodium	Bryant Ranch Prepack	ANDA	Current
71335-1115	Fosinopril sodium	fosinopril sodium	Bryant Ranch Prepack	ANDA	Current
71335-1115	Fosinopril sodium	fosinopril sodium	Bryant Ranch Prepack	ANDA	Current