Application 077222

Type: ANDA
Sponsor: INVAGEN PHARMS

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
A077222-001	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20
A077222-002	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20
A077222-003	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077222-001	AB
A077222-002	AB
A077222-003	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	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`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	A077222-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077222-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077222-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077222-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077222-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077222-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077222-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077222-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077222-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077222-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077222-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077222-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077222-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosinopril Sodium	FOSINOPRIL	Bryant Ranch Prepack	fc38f1bb-f175-4a81-8ed9-c8701efdea35	2023-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222 ndc (product): 71335-0381
Fosinopril Sodium	FOSINOPRIL	Bryant Ranch Prepack	6562a532-b502-4515-88df-591d71293b56	2023-10-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222 ndc (product): 71335-0187
Fosinopril sodium	FOSINOPRIL SODIUM	Exelan Pharmaceuticals, Inc.	e2ff3171-a17a-456a-9272-ca1682b01d19	2023-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222 ndc (product): 76282-201 ndc (product): 76282-202 ndc (product): 76282-200
Fosinopril Sodium	FOSINOPRIL	A-S Medication Solutions	880e5bf4-ced8-4765-a5c2-2361fd06ed9c	2023-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222 ndc (product): 50090-2500 ndc (product): 50090-2977
Fosinopril Sodium	FOSINOPRIL	Cipla USA Inc.	736fe52f-69fb-48b2-b1c5-f06531878538	2023-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222 ndc (product): 69097-857 ndc (product): 69097-856 ndc (product): 69097-858

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-200	Fosinopril Sodium	Fosinopril Sodium	Camber Pharmceuticals Inc.	ANDA	Current
31722-201	Fosinopril Sodium	Fosinopril Sodium	Camber Pharmceuticals Inc.	ANDA	Current
31722-202	Fosinopril Sodium	Fosinopril Sodium	Camber Pharmceuticals Inc.	ANDA	Current
43353-870	Fosinopril sodium	Fosinopril sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-1112	Fosinopril Sodium	Fosinopril Sodium	A-S Medication Solutions	ANDA	Current
50090-1504	Fosinopril Sodium	Fosinopril Sodium	A-S Medication Solutions	ANDA	Current
50090-2500	Fosinopril Sodium	Fosinopril	A-S Medication Solutions	ANDA	Current
50090-2500	Fosinopril Sodium	Fosinopril	A-S Medication Solutions	ANDA	Current
50090-2500	Fosinopril Sodium	Fosinopril	A-S Medication Solutions	ANDA	Current
50090-2977	Fosinopril Sodium	Fosinopril	A-S Medication Solutions	ANDA	Current
50090-3428	Fosinopril sodium	Fosinopril sodium	A-S Medication Solutions	ANDA	Current
50090-3444	Fosinopril sodium	Fosinopril sodium	A-S Medication Solutions	ANDA	Current
50436-0274	Fosinopril Sodium	Fosinopril Sodium	Unit Dose Services	ANDA	Current
50436-3138	Fosinopril Sodium	Fosinopril Sodium	Unit Dose Services	ANDA	Current
53217-277	Fosinopril sodium	Fosinopril sodium	Aidarex Pharmaceuticals LLC	ANDA	Current
53217-278	Fosinopril sodium	Fosinopril sodium	Aidarex Pharmaceuticals LLC	ANDA	Current
63629-5279	Fosinopril Sodium	Fosinopril Sodium	Bryant Ranch Prepack	ANDA	Current
63629-6994	Fosinopril Sodium	Fosinopril Sodium	Bryant Ranch Prepack	ANDA	Current
63629-6994	Fosinopril Sodium	Fosinopril Sodium	Bryant Ranch Prepack	ANDA	Current
63629-7293	Fosinopril Sodium	Fosinopril	Bryant Ranch Prepack	ANDA	Current
63629-7293	Fosinopril Sodium	Fosinopril	Bryant Ranch Prepack	ANDA	Current
63629-7663	Fosinopril Sodium	Fosinopril	Bryant Ranch Prepack	ANDA	Current
63629-7663	Fosinopril Sodium	Fosinopril	Bryant Ranch Prepack	ANDA	Current
67544-431	Fosinopril sodium	Fosinopril sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68788-7717	Fosinopril Sodium	Fosinopril	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7717	Fosinopril Sodium	Fosinopril	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7717	Fosinopril Sodium	Fosinopril	Preferred Pharmaceuticals, Inc.	ANDA	Current
69097-856	Fosinopril Sodium	Fosinopril	Cipla USA Inc.	ANDA	Current
69097-856	Fosinopril Sodium	Fosinopril	Cipla USA Inc.	ANDA	Current
69097-856	Fosinopril Sodium	Fosinopril	Cipla USA Inc.	ANDA	Current
69097-857	Fosinopril Sodium	Fosinopril	Cipla USA Inc.	ANDA	Current
69097-857	Fosinopril Sodium	Fosinopril	Cipla USA Inc.	ANDA	Current
69097-857	Fosinopril Sodium	Fosinopril	Cipla USA Inc.	ANDA	Current
69097-858	Fosinopril Sodium	Fosinopril	Cipla USA Inc.	ANDA	Current
69097-858	Fosinopril Sodium	Fosinopril	Cipla USA Inc.	ANDA	Current
69097-858	Fosinopril Sodium	Fosinopril	Cipla USA Inc.	ANDA	Current
71335-0187	Fosinopril Sodium	Fosinopril	Bryant Ranch Prepack	ANDA	Current
71335-0187	Fosinopril Sodium	Fosinopril	Bryant Ranch Prepack	ANDA	Current
71335-0187	Fosinopril Sodium	Fosinopril	Bryant Ranch Prepack	ANDA	Current
71335-0381	Fosinopril Sodium	Fosinopril	Bryant Ranch Prepack	ANDA	Current
71335-0381	Fosinopril Sodium	Fosinopril	Bryant Ranch Prepack	ANDA	Current
71335-0381	Fosinopril Sodium	Fosinopril	Bryant Ranch Prepack	ANDA	Current
76282-200	Fosinopril sodium	Fosinopril sodium	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-200	Fosinopril sodium	Fosinopril sodium	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-201	Fosinopril sodium	Fosinopril sodium	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-201	Fosinopril sodium	Fosinopril sodium	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-202	Fosinopril sodium	Fosinopril sodium	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-202	Fosinopril sodium	Fosinopril sodium	Exelan Pharmaceuticals, Inc.	ANDA	Current