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 3 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	e285434f-d831-b6e7-e053-2995a90a1ab2	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	84ee5fbf-7299-4b8a-e053-2a91aa0aa159	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Advagen Pharma Limited	205291ba-86a7-43e1-be47-bc75df1921f9	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	Advagen Pharma Ltd	7a7d3ca1-05b0-4c7e-aefa-492cc441585d	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: CARVEDILOL generic name: CARVEDILOL
Carvedilol	CARVEDILOL	A-S Medication Solutions	3eb4fd8e-1027-4d24-8f2f-12e9dcfe6231	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	A-S Medication Solutions	add1ee3d-fca4-4301-b871-7dda6eda7bb7	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Golden State Medical Supply, Inc.	454054f1-0730-41b3-844a-c7b65f1b47c5	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	A-S Medication Solutions	3724c7f1-dd2a-4bc9-b388-17238d663860	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	A-S Medication Solutions	157f64c6-2c21-4056-b643-79047ca237a9	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	UNICHEM PHARMACEUTICALS (USA), INC.	33dfcf29-19d6-46ba-b8ed-d59d2226ad07	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	A-S Medication Solutions	ee848543-12fb-446c-86db-bf2322ec986f	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	PD-Rx Pharmaceuticals, Inc.	444ee05c-571a-4ea6-8763-af05d252df56	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	A-S Medication Solutions	f0617fa4-1e87-48fa-947a-e4249153a947	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	A-S Medication Solutions	3c8d54e6-835c-4fa7-b13b-b798916cfed3	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	A-S Medication Solutions	dd8b2a3f-c2fa-4859-84a1-c02f2b608748	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	A-S Medication Solutions	5eeeaeee-9698-493f-9aa7-d13068147208	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: CARVEDILOL generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	A-S Medication Solutions	947baca7-f9c8-4821-b47b-53c45288613e	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: CARVEDILOL generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Quallent Pharmaceuticals Health LLC	eb892787-edd0-4ab6-aef2-2d0216384395	2026-01-03	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Northwind Health Company, LLC	df7415ac-e475-19c9-e053-2995a90afa71	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Northwind Health Company, LLC	b0887c72-bc6a-010d-e053-2995a90aab8d	2026-01-01	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