Application 078745

Type: ANDA
Sponsor: CHARTWELL MOLECULAR

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
A078745-001	RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18
A078745-002	RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18
A078745-003	RAMIPRIL	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18
A078745-004	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
A078745-001	AB
A078745-002	AB
A078745-003	AB
A078745-004	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	A078745-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078745-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078745-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078745-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078745-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078745-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078745-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078745-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078745-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078745-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078745-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078745-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078745-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078745-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078745-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078745-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078745-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078745-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078745-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078745-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078745-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078745-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078745-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078745-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078745-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078745-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078745-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078745-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078745-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078745-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078745-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078745-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078745-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078745-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078745-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078745-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078745-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078745-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078745-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078745-004	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	A078745-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078745-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078745-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078745-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078745-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078745-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078745-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078745-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078745-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078745-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078745-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078745-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078745-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078745-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078745-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078745-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078745-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078745-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078745-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078745-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078745-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078745-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078745-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078745-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078745-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078745-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078745-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078745-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078745-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078745-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078745-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078745-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078745-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078745-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078745-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078745-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078745-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078745-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078745-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078745-004	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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramipril	RAMIPRIL	Chartwell RX, LLC.	b7e49f05-6d4f-465a-b0d7-f704466a2e52	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078745 application number: ANDA078745 ndc (product): 62135-272 ndc (product): 62135-273 ndc (product): 62135-271 ndc (product): 62135-274

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-271	Ramipril	Ramipril	Camber Pharmaceuticals	ANDA	Current
31722-272	Ramipril	Ramipril	Camber Pharmaceuticals	ANDA	Current
31722-273	Ramipril	Ramipril	Camber Pharmaceuticals	ANDA	Current
31722-274	Ramipril	Ramipril	Camber Pharmaceuticals	ANDA	Current
42291-692	Ramipril	Ramipril	AvKARE, Inc.	ANDA	Current
62135-271	Ramipril	Ramipril	Chartwell RX, LLC.	ANDA	Current
62135-271	Ramipril	Ramipril	Chartwell RX, LLC.	ANDA	Current
62135-272	Ramipril	Ramipril	Chartwell RX, LLC.	ANDA	Current
62135-272	Ramipril	Ramipril	Chartwell RX, LLC.	ANDA	Current
62135-273	Ramipril	Ramipril	Chartwell RX, LLC.	ANDA	Current
62135-273	Ramipril	Ramipril	Chartwell RX, LLC.	ANDA	Current
62135-274	Ramipril	Ramipril	Chartwell RX, LLC.	ANDA	Current
62135-274	Ramipril	Ramipril	Chartwell RX, LLC.	ANDA	Current
76282-271	Ramipril	Ramipril	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-272	Ramipril	Ramipril	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-273	Ramipril	Ramipril	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-274	Ramipril	Ramipril	Exelan Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44395	ORIG	2008-07-01