Application 078384

Type: ANDA
Sponsor: BEXIMCO USA

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 42.

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
A078384-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05
A078384-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A078384-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A078384-004	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
A078384-001	AB
A078384-002	AB
A078384-003	AB
A078384-004	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 · 168 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
2026-08-18 06:07:40	2026-07	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078384-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078384-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078384-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078384-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078384-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078384-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078384-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078384-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078384-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078384-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078384-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078384-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-004	AB	1	`d8e5a09893c0…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	cc3a9614-3017-4775-988e-6e5bd4621b70	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384 ndc (product): 71335-1407
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	45233e64-26ee-4117-a896-24363b435fc2	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384 ndc (product): 71335-1457
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	21191d89-16f6-49a8-9394-f31d0950deea	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384 ndc (product): 71335-1813
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	7aae1a4a-5d0e-4b19-9e4c-55707a9bb184	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Golden State Medical Supply, Inc.	454054f1-0730-41b3-844a-c7b65f1b47c5	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384 ndc (product): 51407-039 ndc (product): 51407-041 ndc (product): 51407-040 ndc (product): 51407-042
Carvedilol	CARVEDILOL	UNICHEM PHARMACEUTICALS (USA), INC.	33dfcf29-19d6-46ba-b8ed-d59d2226ad07	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384 ndc (product): 76385-110 ndc (product): 76385-111
Carvedilol	CARVEDILOL	Northwind Health Company, LLC	df7415ac-e475-19c9-e053-2995a90afa71	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384 ndc (product): 51655-943
Carvedilol	CARVEDILOL	Northwind Health Company, LLC	db5d9e64-46b3-92d3-e053-2995a90a74bc	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Direct_Rx	462a9678-d2cd-d2b8-e063-6294a90a0139	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Coupler LLC	441dda59-c3c4-d3c6-e063-6394a90a98dc	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Proficient Rx LP	a1344411-fc64-4233-89ba-e90a1953e150	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	a7bfd0fc-054b-7397-e053-2a95a90ae3e2	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384 ndc (product): 68071-5275
Carvedilol	CARVEDILOL	Aphena Pharma Solutions - Tennessee, LLC	e3f463b5-2743-4a4a-a90a-bf1ee10a5458	2018-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384 ndc (product): 71610-067 ndc (product): 71610-063 ndc (product): 71610-066 ndc (product): 71610-062

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 90 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-633	Carvedilol	Carvedilol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-633	Carvedilol	Carvedilol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-634	Carvedilol	Carvedilol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-634	Carvedilol	Carvedilol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-635	Carvedilol	Carvedilol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-635	Carvedilol	Carvedilol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-637	Carvedilol	Carvedilol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-637	Carvedilol	Carvedilol	Marlex Pharmaceuticals Inc	ANDA	Current
43547-254	Carvedilol	Carvedilol	Solco Healthcare US LLC	ANDA	Current
43547-254	Carvedilol	Carvedilol	Solco Healthcare US LLC	ANDA	Current
43547-254	Carvedilol	Carvedilol	Solco Healthcare US LLC	ANDA	Current
43547-255	Carvedilol	Carvedilol	Solco Healthcare US LLC	ANDA	Current
43547-255	Carvedilol	Carvedilol	Solco Healthcare US LLC	ANDA	Current
43547-255	Carvedilol	Carvedilol	Solco Healthcare US LLC	ANDA	Current
43547-256	Carvedilol	Carvedilol	Solco Healthcare US LLC	ANDA	Current
43547-256	Carvedilol	Carvedilol	Solco Healthcare US LLC	ANDA	Current
43547-256	Carvedilol	Carvedilol	Solco Healthcare US LLC	ANDA	Current
43547-257	Carvedilol	Carvedilol	Solco Healthcare US LLC	ANDA	Current
43547-257	Carvedilol	Carvedilol	Solco Healthcare US LLC	ANDA	Current
43547-257	Carvedilol	Carvedilol	Solco Healthcare US LLC	ANDA	Current
51407-039	Carvedilol	Carvedilol	Golden State Medical Supply Inc.	ANDA	Current
51407-039	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-039	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-039	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-039	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-040	Carvedilol	Carvedilol	Golden State Medical Supply Inc.	ANDA	Current
51407-040	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-040	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-040	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-040	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-041	Carvedilol	Carvedilol	Golden State Medical Supply Inc.	ANDA	Current
51407-041	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-041	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-041	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-041	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-042	Carvedilol	Carvedilol	Golden State Medical Supply Inc.	ANDA	Current
51407-042	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-042	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-042	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51407-042	Carvedilol	Carvedilol	Golden State Medical Supply, Inc.	ANDA	Current
51655-943	Carvedilol	Carvedilol	Northwind Pharmaceuticals	ANDA	Current
53808-1024	Carvedilol	Carvedilol	State of Florida DOH Central Pharmacy	ANDA	Current
55700-819	Carvedilol	Carvedilol	Quality Care Products, LLC	ANDA	Current
55700-819	Carvedilol	Carvedilol	Quality Care Products, LLC	ANDA	Current
60760-376	Carvedilol	Carvedilol	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-533	CARVEDILOL	CARVEDILOL	DIRECT RX	ANDA	Current
61919-533	CARVEDILOL	CARVEDILOL	DIRECT RX	ANDA	Current
68071-2633	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5275	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5275	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7883	Carvedilol	Carvedilol	Preferred Pharmacdeuticals Inc	ANDA	Current
68788-7883	Carvedilol	Carvedilol	Preferred Pharmacdeuticals Inc	ANDA	Current
70518-0564	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0564	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1797	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1797	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70934-874	Carvedilol	Carvedilol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-910	Carvedilol	Carvedilol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-910	Carvedilol	Carvedilol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-910	Carvedilol	Carvedilol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1407	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
71335-1407	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
71335-1457	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
71335-1457	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
71335-1813	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
71335-1813	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
71610-062	Carvedilol	Carvedilol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-063	Carvedilol	Carvedilol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-066	Carvedilol	Carvedilol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-067	Carvedilol	Carvedilol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76385-110	Carvedilol	Carvedilol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-110	Carvedilol	Carvedilol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-110	Carvedilol	Carvedilol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-110	Carvedilol	Carvedilol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-110	Carvedilol	Carvedilol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-111	Carvedilol	Carvedilol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-111	Carvedilol	Carvedilol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-111	Carvedilol	Carvedilol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-111	Carvedilol	Carvedilol	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-111	Carvedilol	Carvedilol	Bayshore Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9153	ORIG	2007-09-07