Application 091604

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RAMIPRIL	RAMIPRIL	CAPSULE;ORAL	1.25MG	No	No
002	RAMIPRIL	RAMIPRIL	CAPSULE;ORAL	2.5MG	No	No
003	RAMIPRIL	RAMIPRIL	CAPSULE;ORAL	5MG	No	No
004	RAMIPRIL	RAMIPRIL	CAPSULE;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091604-001	RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08
A091604-002	RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08
A091604-003	RAMIPRIL	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08
A091604-004	RAMIPRIL	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A091604-001	AB
A091604-002	AB
A091604-003	AB
A091604-004	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 5 · 172 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	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091604-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091604-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091604-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091604-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091604-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091604-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091604-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091604-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091604-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091604-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-004	AB	1	`5bbf6a4d5a75…`

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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramipril	RAMIPRIL	Proficient Rx LP	543914e5-c164-4fc7-8007-9fab2b13dda7	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Proficient Rx LP	d3513b8b-2d8a-456d-b942-a25ec1965b04	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 95 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-588	Ramipril	Ramipril	Blenheim Pharmacal, Inc.	ANDA	Current
33261-903	Ramipril	Ramipril	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-967	Ramipril	Ramipril	Aidarex Pharmaceuticals LLC	ANDA	Current
45865-443	Ramipril	Ramipril	Medsource Pharmaceuticals	ANDA	Current
50090-1118	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
50090-1120	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
50090-3873	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
50090-3873	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
50090-5673	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
50090-5730	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
50090-5947	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
57237-222	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-222	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-222	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-222	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-223	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-223	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-223	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-223	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-224	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-224	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-224	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-224	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-225	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-225	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-225	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
57237-225	Ramipril	Ramipril	Rising Health, LLC	ANDA	Current
60760-476	Ramipril	Ramipril	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-477	Ramipril	Ramipril	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-481	Ramipril	Ramipril	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-571	Ramipril	Ramipril	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-833	RAMIPRIL	RAMIPRIL	DIRECT RX	ANDA	Current
63187-816	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-816	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-915	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-915	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63629-1254	Ramipril	Ramipril	Bryant Ranch Prepack	ANDA	Current
63629-1254	Ramipril	Ramipril	Bryant Ranch Prepack	ANDA	Current
63629-7260	Ramipril	Ramipril	Bryant Ranch Prepack	ANDA	Current
65862-474	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-474	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-474	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-474	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-474	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-475	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-475	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-475	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-475	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-475	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-476	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-476	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-476	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-476	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-476	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-477	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-477	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-477	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-477	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
65862-477	Ramipril	Ramipril	Aurobindo Pharma Limited	ANDA	Current
68001-428	Ramipril	Ramipril	BluePoint Laboratories	ANDA	Current
68001-428	Ramipril	Ramipril	BluePoint Laboratories	ANDA	Current
68001-428	Ramipril	Ramipril	BluePoint Laboratories	ANDA	Current
68001-429	Ramipril	Ramipril	BluePoint Laboratories	ANDA	Current
68001-429	Ramipril	Ramipril	BluePoint Laboratories	ANDA	Current
68001-429	Ramipril	Ramipril	BluePoint Laboratories	ANDA	Current
68001-430	Ramipril	Ramipril	BluePoint Laboratories	ANDA	Current
68001-430	Ramipril	Ramipril	BluePoint Laboratories	ANDA	Current
68001-430	Ramipril	Ramipril	BluePoint Laboratories	ANDA	Current
68001-431	Ramipril	Ramipril	BluePoint Laboratories	ANDA	Current
68001-431	Ramipril	Ramipril	BluePoint Laboratories	ANDA	Current
68001-431	Ramipril	Ramipril	BluePoint Laboratories	ANDA	Current
68788-7008	Ramipril	Ramipril	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7198	Ramipril	Ramipril	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1200	Ramipril	Ramipril	REMEDYREPACK INC.	ANDA	Current
70518-1200	Ramipril	Ramipril	REMEDYREPACK INC.	ANDA	Current
70518-1200	Ramipril	Ramipril	REMEDYREPACK INC.	ANDA	Current
70518-1200	Ramipril	Ramipril	REMEDYREPACK INC.	ANDA	Current
70518-1200	Ramipril	Ramipril	REMEDYREPACK INC.	ANDA	Current
70518-1200	Ramipril	Ramipril	REMEDYREPACK INC.	ANDA	Current
70518-1200	Ramipril	Ramipril	REMEDYREPACK INC.	ANDA	Current