Application 078191

Type: ANDA
Sponsor: DR REDDYS LABS 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 1.

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
A078191-001	RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18
A078191-002	RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18
A078191-003	RAMIPRIL	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18
A078191-004	RAMIPRIL	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078191-001	AB
A078191-002	AB
A078191-003	AB
A078191-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A078191-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078191-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078191-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078191-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078191-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078191-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078191-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078191-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078191-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078191-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078191-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078191-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078191-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078191-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078191-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078191-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078191-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078191-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078191-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078191-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078191-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078191-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078191-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078191-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078191-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078191-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078191-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078191-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078191-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078191-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078191-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078191-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078191-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078191-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078191-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078191-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078191-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078191-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078191-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078191-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078191-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078191-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078191-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078191-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078191-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078191-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078191-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078191-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078191-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078191-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078191-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078191-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078191-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078191-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078191-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078191-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078191-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078191-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078191-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078191-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078191-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078191-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078191-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078191-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078191-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078191-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078191-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078191-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078191-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078191-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078191-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078191-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078191-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078191-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078191-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078191-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078191-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078191-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078191-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078191-004	AB	1	`d06236e962d9…`

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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramipril	RAMIPRIL	Bryant Ranch Prepack	3806abdc-6aec-4252-bd79-e2c115b849aa	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Aurobindo Pharma Limited	d6d57158-e8f9-4c91-8317-0374e0c87d33	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Lupin Pharmaceuticals, Inc.	a8cdec12-81d1-4ef4-82c0-d05d93c37a07	2026-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Zydus Pharmaceuticals USA Inc.	055bb582-67cd-425a-8823-d543c14305ce	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Bryant Ranch Prepack	ef05b44e-4bf7-4afa-a5f6-06efa0d0abc3	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Bryant Ranch Prepack	8be00433-3113-437e-8ab6-721af4d79185	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Bryant Ranch Prepack	d270b634-0d6d-4614-b223-a2af1e238c2f	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Hikma Pharmaceuticals USA Inc.	7e9e84f7-ff47-463d-bf47-7a9745960aae	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	REMEDYREPACK INC.	f6c86139-b1f7-4e84-944f-94af883ce4ea	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	REMEDYREPACK INC.	fcf42121-8e85-4eae-82b4-bc029653b462	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	NuCare Pharmaceuticals, Inc.	4bd2d586-6851-4a40-e063-6394a90a0cab	2026-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	REMEDYREPACK INC.	394a49a8-81bb-43ba-8d6a-fa6fa5030587	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	A-S Medication Solutions	e8d9a115-71a7-4580-abbd-865e98b5d3f6	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	A-S Medication Solutions	d856fb57-f1a0-49e6-bb2d-b4924af48515	2026-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	A-S Medication Solutions	a3786664-a1b5-4914-99d6-79fb0e330e98	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Chartwell RX, LLC.	b7e49f05-6d4f-465a-b0d7-f704466a2e52	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Northwind Health Company, LLC	f2b87655-93c3-16a5-e053-2a95a90a593c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Northwind Health Company, LLC	ab3124b7-deed-8e04-e053-2a95a90a3b85	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Northwind Health Company, LLC	f2f325b8-f33d-3b93-e053-2995a90aa660	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL
Ramipril	RAMIPRIL	Northwind Health Company, LLC	f7e61b5b-fb5b-ba15-e053-6394a90adc3c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ramipril generic name: RAMIPRIL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55111-438	Ramipril	Ramipril	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-438	Ramipril	Ramipril	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-439	Ramipril	Ramipril	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-439	Ramipril	Ramipril	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-440	Ramipril	Ramipril	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-440	Ramipril	Ramipril	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-441	Ramipril	Ramipril	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-441	Ramipril	Ramipril	Dr. Reddy's Laboratories Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44376	ORIG	2008-07-01