Application 076906

Type: ANDA
Sponsor: APOTEX 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 43.

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	Approval date
A076906-001	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2005-05-17
A076906-002	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2005-05-17
A076906-003	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2005-05-17

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 · 129 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
2026-09-14 22:38:34	2026-08	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL		2005-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL		2005-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL		2005-05-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL		2005-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL		2005-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL		2005-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL		2005-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL		2005-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL		2005-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL		2005-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL		2005-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL		2005-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL		2005-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL		2005-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL		2005-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076906-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076906-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076906-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-05-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A076906-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076906-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076906-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076906-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076906-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076906-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076906-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076906-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076906-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076906-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076906-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076906-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076906-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076906-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076906-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076906-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076906-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076906-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076906-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076906-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076906-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076906-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076906-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076906-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076906-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076906-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076906-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076906-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076906-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076906-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076906-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076906-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076906-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076906-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076906-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076906-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076906-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076906-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076906-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076906-002	AB	1	`ea1830bbd6c7…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosinopril Sodium	FOSINOPRIL SODIUM	Chartwell RX, LLC	ff1323cc-7ad8-488d-94a7-a11555db78a7	2025-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril Sodium generic name: FOSINOPRIL SODIUM
Fosinopril Sodium	FOSINOPRIL SODIUM	Aurobindo Pharma Limited	aee04f17-8ee9-42f5-861f-b6ba17220ca4	2024-05-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril Sodium generic name: FOSINOPRIL SODIUM
Fosinopril Sodium	FOSINOPRIL	Bryant Ranch Prepack	fc38f1bb-f175-4a81-8ed9-c8701efdea35	2023-11-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril Sodium
Fosinopril sodium	FOSINOPIRL SODIUM	Bryant Ranch Prepack	3d521d4d-29f8-40d7-971b-0efb68dfbff2	2023-11-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril sodium
Fosinopril Sodium	FOSINOPRIL	Bryant Ranch Prepack	6562a532-b502-4515-88df-591d71293b56	2023-10-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril Sodium
Fosinopril sodium	FOSINOPRIL SODIUM	A-S Medication Solutions	46e3e4e8-c611-4d4f-ad57-050b4c01fcd8	2023-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril sodium generic name: FOSINOPRIL SODIUM
Fosinopril sodium	FOSINOPRIL SODIUM	Bryant Ranch Prepack	ee78de8e-22f4-4c3b-a721-e9464d704eda	2023-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril sodium generic name: FOSINOPRIL SODIUM
Fosinopril sodium	FOSINOPRIL SODIUM	Exelan Pharmaceuticals, Inc.	e2ff3171-a17a-456a-9272-ca1682b01d19	2023-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril sodium generic name: FOSINOPRIL SODIUM
Fosinopril Sodium	FOSINOPRIL	A-S Medication Solutions	880e5bf4-ced8-4765-a5c2-2361fd06ed9c	2023-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril Sodium
Fosinopril Sodium	FOSINOPRIL	Cipla USA Inc.	736fe52f-69fb-48b2-b1c5-f06531878538	2023-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril Sodium
Fosinopril sodium	FOSINOPIRL SODIUM	Solco Healthcare LLC	0a66f606-5e6f-473d-8a1e-9ef316adb2e2	2021-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fosinopril sodium generic name: FOSINOPRIL SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.