Application 077474

Type: ANDA
Sponsor: CHARTWELL MOLECULAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARVEDILOL	CARVEDILOL	TABLET;ORAL	3.125MG	No	No
002	CARVEDILOL	CARVEDILOL	TABLET;ORAL	6.25MG	No	No
003	CARVEDILOL	CARVEDILOL	TABLET;ORAL	12.5MG	No	No
004	CARVEDILOL	CARVEDILOL	TABLET;ORAL	25MG	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
A077474-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05
A077474-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A077474-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A077474-004	CARVEDILOL	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077474-001	AB
A077474-002	AB
A077474-003	AB
A077474-004	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	A077474-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077474-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077474-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077474-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077474-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077474-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077474-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077474-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077474-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077474-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077474-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077474-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077474-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077474-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077474-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077474-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077474-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077474-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077474-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077474-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077474-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077474-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077474-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077474-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077474-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077474-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077474-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077474-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077474-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077474-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077474-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077474-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077474-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077474-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077474-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077474-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077474-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077474-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077474-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077474-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`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	A077474-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077474-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077474-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077474-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077474-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077474-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077474-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077474-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077474-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077474-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077474-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077474-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077474-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077474-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077474-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077474-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077474-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077474-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077474-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077474-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077474-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077474-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077474-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077474-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077474-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077474-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077474-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077474-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077474-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077474-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077474-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077474-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077474-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077474-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077474-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077474-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077474-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077474-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077474-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077474-004	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 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	Redpharm Drug	58337744-a130-35ef-e063-6294a90a080b	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Coupler LLC	58280d18-5960-1730-e063-6394a90a4f64	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Coreg	CARVEDILOL	Waylis Therapeutics LLC	07c619c6-4a0c-445e-94fa-664a54f68a39	2026-07-31	Warnings, Adverse reactions	Name fallback generic name: CARVEDILOL
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	ab8aa773-0ed1-4d59-a1bb-f46cf882644f	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	PD-Rx Pharmaceuticals, Inc.	95300809-be15-461e-904e-b56aba676975	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: CARVEDILOL generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	PD-Rx Pharmaceuticals, Inc.	9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa9	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: CARVEDILOL generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	NuCare Pharmaceuticals, Inc.	574c419f-3b9e-2171-e063-6394a90a0e90	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: CARVEDILOL generic name: CARVEDILOL
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	0e98593a-8424-48c8-acc0-671f4b566aee	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	32098c09-7580-4975-a3e1-31b619c04c69	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	196536eb-8b94-45da-a2f3-f554d6bf88e9	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	39cf31cc-8f3d-4919-a93a-f997ad6850dc	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	cc3a9614-3017-4775-988e-6e5bd4621b70	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	45233e64-26ee-4117-a896-24363b435fc2	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Major Pharmaceuticals	ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	6eec3476-f6db-45bd-bb91-4b2d5fbd0f5f	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	St. Mary's Medical Park Pharmacy	ed11cd4e-d7c9-8446-e053-2995a90afd6e	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	03b7c07c-14ba-40c8-8c0a-8dfa4a10f580	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: CARVEDILOL generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	fe462198-32ae-4f6c-befc-acb97fb017c9	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: CARVEDILOL generic name: CARVEDILOL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-263	CARVEDILOL	carvedilol	Cipla USA Inc.	ANDA	Current
69097-264	CARVEDILOL	carvedilol	Cipla USA Inc.	ANDA	Current
69097-265	CARVEDILOL	carvedilol	Cipla USA Inc.	ANDA	Current
69097-266	CARVEDILOL	carvedilol	Cipla USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9051	ORIG	2007-09-07