Application 091163

Type: ANDA
Sponsor: AUROBINDO PHARMA 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 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
A091163-001	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30
A091163-002	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30
A091163-003	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091163-001	AB
A091163-002	AB
A091163-003	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	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091163-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2011-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091163-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2011-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091163-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2011-03-30	`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	A091163-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091163-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091163-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091163-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091163-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091163-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091163-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091163-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091163-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091163-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091163-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091163-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091163-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091163-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091163-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091163-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091163-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091163-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091163-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091163-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091163-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091163-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091163-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091163-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091163-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091163-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091163-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091163-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091163-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091163-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091163-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091163-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091163-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091163-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091163-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091163-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091163-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091163-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091163-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091163-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosinopril Sodium	FOSINOPRIL SODIUM	Aurobindo Pharma Limited	aee04f17-8ee9-42f5-861f-b6ba17220ca4	2024-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091163 application number: ANDA091163 ndc (product): 65862-472 ndc (product): 65862-471 ndc (product): 65862-473

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-770	Fosinopril Sodium	Fosinopril Sodium	Rising Pharma Holdings, Inc.	ANDA	Current
16571-771	Fosinopril Sodium	Fosinopril Sodium	Rising Pharma Holdings, Inc.	ANDA	Current
16571-772	Fosinopril Sodium	Fosinopril Sodium	Rising Pharma Holdings, Inc.	ANDA	Current
65862-471	Fosinopril Sodium	Fosinopril Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-471	Fosinopril Sodium	Fosinopril Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-471	Fosinopril Sodium	Fosinopril Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-472	Fosinopril Sodium	Fosinopril Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-472	Fosinopril Sodium	Fosinopril Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-472	Fosinopril Sodium	Fosinopril Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-473	Fosinopril Sodium	Fosinopril Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-473	Fosinopril Sodium	Fosinopril Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-473	Fosinopril Sodium	Fosinopril Sodium	Aurobindo Pharma Limited	ANDA	Current