Application 077004

Type: ANDA
Sponsor: CIPLA

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	Approval date
A077004-001	RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-08-07
A077004-002	RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-08-07
A077004-003	RAMIPRIL	RAMIPRIL	5MG	CAPSULE / ORAL	2008-08-07
A077004-004	RAMIPRIL	RAMIPRIL	10MG	CAPSULE / ORAL	2008-08-07

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077004-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077004-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077004-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077004-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077004-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077004-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077004-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077004-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077004-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077004-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077004-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077004-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077004-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077004-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077004-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077004-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077004-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077004-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077004-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077004-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077004-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077004-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077004-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077004-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077004-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077004-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077004-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077004-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077004-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077004-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077004-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077004-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077004-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077004-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077004-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077004-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077004-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077004-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077004-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077004-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-08-07	`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 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramipril	RAMIPRIL	Northwind Health Company, LLC	ab09a67e-18fe-c860-e053-2a95a90a4d03	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Northwind Health Company, LLC	ab324cb3-2aaa-b57f-e053-2995a90a2055	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Northwind Health Company, LLC	fb0892da-3db7-3202-e053-6394a90ab605	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	A-S Medication Solutions	5fb23b7d-ed2b-4984-89c8-d0a509b917e1	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	GSMS, Incorporated	62f6aa5a-7587-4349-b61d-b2c235749979	2025-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	A-S Medication Solutions	1576188e-efd4-4e14-870e-fd9bd2751c45	2025-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	A-S Medication Solutions	dd3162eb-5f09-47ac-9efd-3ddeee695a25	2025-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Zydus Lifesciences Limited	496b346b-ca79-4483-a950-bed9464e6a9d	2024-12-04		Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	A-S Medication Solutions	4a91b706-c614-4472-92f2-4da5d7bdbf27	2024-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Proficient Rx LP	01da05d8-e72e-4208-bf92-a5cd929f15ab	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Exelan Pharmaceuticals, Inc.	1e1dfacf-b831-4743-a874-9a5e5ef8a120	2021-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Proficient Rx LP	33bdfe96-1b7a-4859-b1c9-ef94b8bb7a2a	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Proficient Rx LP	afd766bc-2a42-40b5-b33f-1a8b5ce2622e	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Proficient Rx LP	543914e5-c164-4fc7-8007-9fab2b13dda7	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Proficient Rx LP	d3513b8b-2d8a-456d-b942-a25ec1965b04	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44329	ORIG	2008-09-19