Application 078240

Type: ANDA
Sponsor: PLIVA HRVATSKA DOO

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 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
A078240-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	2007-10-30
A078240-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	2007-10-30
A078240-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	2007-10-30
A078240-004	CARVEDILOL	CARVEDILOL	25MG	TABLET / ORAL	2007-10-30

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	A078240-001	CARVEDILOL	3.125MG	TABLET / ORAL	2007-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078240-002	CARVEDILOL	6.25MG	TABLET / ORAL	2007-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078240-003	CARVEDILOL	12.5MG	TABLET / ORAL	2007-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078240-004	CARVEDILOL	25MG	TABLET / ORAL	2007-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078240-001	CARVEDILOL	3.125MG	TABLET / ORAL	2007-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078240-002	CARVEDILOL	6.25MG	TABLET / ORAL	2007-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078240-003	CARVEDILOL	12.5MG	TABLET / ORAL	2007-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078240-004	CARVEDILOL	25MG	TABLET / ORAL	2007-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078240-001	CARVEDILOL	3.125MG	TABLET / ORAL	2007-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078240-002	CARVEDILOL	6.25MG	TABLET / ORAL	2007-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078240-003	CARVEDILOL	12.5MG	TABLET / ORAL	2007-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078240-004	CARVEDILOL	25MG	TABLET / ORAL	2007-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078240-001	CARVEDILOL	3.125MG	TABLET / ORAL	2007-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078240-002	CARVEDILOL	6.25MG	TABLET / ORAL	2007-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078240-003	CARVEDILOL	12.5MG	TABLET / ORAL	2007-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078240-004	CARVEDILOL	25MG	TABLET / ORAL	2007-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078240-001	CARVEDILOL	3.125MG	TABLET / ORAL	2007-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078240-002	CARVEDILOL	6.25MG	TABLET / ORAL	2007-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078240-003	CARVEDILOL	12.5MG	TABLET / ORAL	2007-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078240-004	CARVEDILOL	25MG	TABLET / ORAL	2007-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078240-001	CARVEDILOL	3.125MG	TABLET / ORAL	2007-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078240-002	CARVEDILOL	6.25MG	TABLET / ORAL	2007-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078240-003	CARVEDILOL	12.5MG	TABLET / ORAL	2007-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078240-004	CARVEDILOL	25MG	TABLET / ORAL	2007-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078240-001	CARVEDILOL	3.125MG	TABLET / ORAL	2007-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078240-002	CARVEDILOL	6.25MG	TABLET / ORAL	2007-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078240-003	CARVEDILOL	12.5MG	TABLET / ORAL	2007-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078240-004	CARVEDILOL	25MG	TABLET / ORAL	2007-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078240-001	CARVEDILOL	3.125MG	TABLET / ORAL	2007-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078240-002	CARVEDILOL	6.25MG	TABLET / ORAL	2007-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078240-003	CARVEDILOL	12.5MG	TABLET / ORAL	2007-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078240-004	CARVEDILOL	25MG	TABLET / ORAL	2007-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078240-001	CARVEDILOL	3.125MG	TABLET / ORAL	2007-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078240-002	CARVEDILOL	6.25MG	TABLET / ORAL	2007-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078240-003	CARVEDILOL	12.5MG	TABLET / ORAL	2007-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078240-004	CARVEDILOL	25MG	TABLET / ORAL	2007-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078240-001	CARVEDILOL	3.125MG	TABLET / ORAL	2007-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078240-002	CARVEDILOL	6.25MG	TABLET / ORAL	2007-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078240-003	CARVEDILOL	12.5MG	TABLET / ORAL	2007-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078240-004	CARVEDILOL	25MG	TABLET / ORAL	2007-10-30	`5bbf6a4d5a75…`

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 2 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Carvedilol	CARVEDILOL	Coupler LLC	52bd1d20-08ba-1e5e-e063-6294a90ae8a9	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	1ddff189-1848-4186-bca9-063e4ea7fd1f	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: CARVEDILOL generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	d7669550-adcc-4e70-83b1-c28ce75e7fda	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	21191d89-16f6-49a8-9394-f31d0950deea	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Coupler LLC	51b403dc-fc9f-0cad-e063-6394a90af081	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	QPharma Inc	010290af-81f4-0037-e063-6394a90a4638	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	7aae1a4a-5d0e-4b19-9e4c-55707a9bb184	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	A-S Medication Solutions	fe2d5c95-c101-4b01-89fd-0fd6d25ad80b	2026-04-26	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Cardinal Health 107, LLC	bd0f2596-a192-4b0e-836f-4a09816408a4	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	b23021d4-c00a-e0ef-eb93-1dc824ae56ca	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Preferred Pharmaceuticals, Inc.	5c34847d-68f9-4967-81c8-a2297a6acb7f	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Preferred Pharmaceuticals Inc.	3b56e0d0-82d7-4512-849f-2b72d7bae36e	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	BluePoint Laboratories	e68c9b18-e7fd-45f7-a8f5-1d815e32680b	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Direct_Rx	4c48ba6b-4e1e-5116-e063-6394a90aa793	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Direct_Rx	4c0e089b-0199-43e2-e063-6394a90a7883	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
Carvedilol	CARVEDILOL	Proficient Rx LP	8db9cddd-0ee7-4ce8-a8c9-c5e043b2838a	2026-03-01	Warnings, Adverse reactions	Name fallback brand name: Carvedilol generic name: CARVEDILOL
CARVEDILOL	CARVEDILOL	NuCare Pharmaceuticals, Inc.	4bbf3767-8666-22d8-e063-6294a90a2afe	2026-02-26	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.