Application 077346

Type: ANDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARVEDILOL	CARVEDILOL	TABLET;ORAL	6.25MG	No	No
002	CARVEDILOL	CARVEDILOL	TABLET;ORAL	12.5MG	No	No
003	CARVEDILOL	CARVEDILOL	TABLET;ORAL	25MG	No	No
004	CARVEDILOL	CARVEDILOL	TABLET;ORAL	3.125MG	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
A077346-001	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05
A077346-002	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05
A077346-003	CARVEDILOL	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05
A077346-004	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05

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	A077346-001	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077346-002	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077346-003	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077346-004	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077346-001	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077346-002	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077346-003	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077346-004	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077346-001	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077346-002	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077346-003	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077346-004	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077346-001	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077346-002	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077346-003	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077346-004	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077346-001	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077346-002	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077346-003	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077346-004	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077346-001	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077346-002	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077346-003	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077346-004	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077346-001	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077346-002	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077346-003	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077346-004	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077346-001	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077346-002	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077346-003	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077346-004	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077346-001	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077346-002	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077346-003	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077346-004	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077346-001	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077346-002	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077346-003	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077346-004	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A077346-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077346-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077346-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077346-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077346-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077346-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077346-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077346-004	AB	1	`ea99ee380514…`

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 5 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	A-S Medication Solutions	f5969d18-46c7-4f35-9668-2fd4f6bbeb17	2025-08-13	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	NCS HealthCare of KY, LLC dba Vangard Labs	2fb46fe1-9b7b-4718-9327-2471af22f0b7	2025-06-11	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Proficient Rx LP	da2696ba-f4be-4626-9abe-fe33f36361b1	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Proficient Rx LP	a1344411-fc64-4233-89ba-e90a1953e150	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	American Health Packaging	a97a2467-7525-467c-8969-38246903690c	2025-02-20	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Preferred Pharmaceuticals,Inc.	81bc612d-5674-45b9-a1f5-2cb4fa625747	2025-02-14	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	Preferred Pharmaceuticals Inc.	8d3937b4-e0dd-4165-9825-bbf5020d79f9	2025-02-14	Warnings, Adverse reactions	Name fallback brand name: CARVEDILOL generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Proficient Rx LP	c0202d0f-2ffc-45f2-a98d-5f05ac1eaa85	2025-02-01	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	RedPharm Drug, Inc	fcb1de7c-1878-1835-e053-6294a90abe95	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: CARVEDILOL generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	RedPharm Drug, Inc	fcb2025f-11a1-ea73-e053-6394a90a61cb	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: CARVEDILOL generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Direct_Rx	e5e766e3-ef75-4100-e053-2995a90a510f	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	ac14846e-423a-37c4-e053-2a95a90a3cdd	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	da830b08-1cdd-4d36-a068-c376fd7763c4	2024-08-22	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	a7bfd0fc-054b-7397-e053-2a95a90ae3e2	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	fe4aa7f0-6ef2-4a95-8a64-5e3365f10474	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Proficient Rx LP	0bfea06d-7abe-407a-80a4-d15d373569f7	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	e31271aa-259b-caa6-e053-2995a90a0fcd	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	8ccf07f5-78fb-76da-e053-2a95a90a0090	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	786e8ad3-a8d7-41e6-e053-2991aa0a32c7	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Aurobindo Pharma Limited	7cc14b86-0833-4c3c-91f3-7963d7052fd5	2024-06-07	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL

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 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-242	Carvedilol	Carvedilol	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-244	Carvedilol	Carvedilol	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-245	Carvedilol	Carvedilol	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-247	Carvedilol	Carvedilol	Sun Pharmaceutical Industries, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39528	ORIG	2007-09-07
31225	ORIG	2007-09-07