Application 076580

Type: ANDA
Sponsor: RANBAXY LABS LTD

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 44.

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
A076580-001	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23
A076580-002	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23
A076580-003	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076580-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	2004-04-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076580-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	2004-04-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076580-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	2004-04-23	`c0c555d07b60…`

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.