Application 077614

Type: ANDA
Sponsor: ZYDUS PHARMS USA 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	TE codes	Approval date
A077614-001	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A077614-002	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A077614-003	CARVEDILOL	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05
A077614-004	CARVEDILOL	CARVEDILOL	3.125MG	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
A077614-001	AB
A077614-002	AB
A077614-003	AB
A077614-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077614-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077614-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077614-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077614-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077614-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077614-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077614-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-004	AB	1	`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 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	Direct_Rx	4c0e089b-0199-43e2-e063-6394a90a7883	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	A-S Medication Solutions	3eb4fd8e-1027-4d24-8f2f-12e9dcfe6231	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	A-S Medication Solutions	add1ee3d-fca4-4301-b871-7dda6eda7bb7	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	A-S Medication Solutions	3724c7f1-dd2a-4bc9-b388-17238d663860	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	A-S Medication Solutions	157f64c6-2c21-4056-b643-79047ca237a9	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	PD-Rx Pharmaceuticals, Inc.	444ee05c-571a-4ea6-8763-af05d252df56	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	A-S Medication Solutions	f0617fa4-1e87-48fa-947a-e4249153a947	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	A-S Medication Solutions	dd8b2a3f-c2fa-4859-84a1-c02f2b608748	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 50090-4171
Carvedilol	CARVEDILOL	Quallent Pharmaceuticals Health LLC	eb892787-edd0-4ab6-aef2-2d0216384395	2026-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Northwind Health Company, LLC	b0887c72-bc6a-010d-e053-2995a90aab8d	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 51655-397
Carvedilol	CARVEDILOL	Zydus Pharmaceuticals USA Inc.	dc6a2d33-aa04-4a04-9cde-901b744d24ca	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 68382-095 ndc (product): 68382-094 ndc (product): 68382-093 ndc (product): 68382-092
Carvedilol	CARVEDILOL	Zydus Lifesciences Limited	29082d8c-bbde-4620-924f-02dcf1764919	2025-12-31		Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 65841-618 ndc (product): 65841-617 ndc (product): 65841-619 ndc (product): 65841-616
Carvedilol	CARVEDILOL	Northwind Health Company, LLC	a570b8ea-530d-4565-a091-bb9dbe4a6d8d	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 51655-029
Carvedilol	CARVEDILOL	Northwind Health Company, LLC	df600dde-8ef9-52e3-e053-2a95a90a2dc0	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 51655-030
Carvedilol	CARVEDILOL	Northwind Health Company, LLC	f2a0407c-2e05-60eb-e053-2a95a90abc99	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	A-S Medication Solutions	ed60e2e4-6eda-4728-aec4-263b821e4ed8	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Proficient Rx LP	d5822e3c-413c-4c7e-bbec-d0d42d2028ba	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 63187-424
Carvedilol	CARVEDILOL	A-S Medication Solutions	64ba2b17-989e-443c-8277-9649489b5ce8	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	American Health Packaging	a97a2467-7525-467c-8969-38246903690c	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 68084-854
Carvedilol	CARVEDILOL	Preferred Pharmaceuticals,Inc.	81bc612d-5674-45b9-a1f5-2cb4fa625747	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614

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 2 · 144 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4171	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
50090-4171	Carvedilol	Carvedilol	A-S Medication Solutions	ANDA	Current
51655-029	CARVEDILOL	CARVEDILOL	Northwind Pharmaceuticals, LLC	ANDA	Current
51655-030	Carvedilol	Carvedilol	Northwind Pharmaceuticals	ANDA	Current
51655-397	Carvedilol	Carvedilol	Northwind Pharmaceuticals	ANDA	Current
51655-397	Carvedilol	Carvedilol	Northwind Pharmaceuticals	ANDA	Current
52959-466	Carvedilol	Carvedilol	H.J. Harkins Company, Inc.	ANDA	Current
53808-0220	Carvedilol	Carvedilol	State of Florida DOH Central Pharmacy	ANDA	Current
60760-494	Carvedilol	Carvedilol	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-582	Carvedilol	Carvedilol	ST. MARY'S MEDICAL PARK PHARMACY	ANDA	Current
63187-424	Carvedilol	Carvedilol	Proficient Rx LP	ANDA	Current
63187-424	Carvedilol	Carvedilol	Proficient Rx LP	ANDA	Current
63187-570	Carvedilol	Carvedilol	Proficient Rx LP	ANDA	Current
63187-570	Carvedilol	Carvedilol	Proficient Rx LP	ANDA	Current
63629-4060	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
63629-4060	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
63629-4060	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
63629-4070	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
63629-8039	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
63629-8039	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
65841-616	Carvedilol	Carvedilol	Cadila Healthcare Limited	ANDA	Current
65841-616	Carvedilol	Carvedilol	Cadila Healthcare Limited	ANDA	Current
65841-616	Carvedilol	Carvedilol	Zydus Lifesciences Limited	ANDA	Current
65841-616	Carvedilol	Carvedilol	Cadila Healthcare Limited	ANDA	Current
65841-617	Carvedilol	Carvedilol	Cadila Healthcare Limited	ANDA	Current
65841-617	Carvedilol	Carvedilol	Cadila Healthcare Limited	ANDA	Current
65841-617	Carvedilol	Carvedilol	Zydus Lifesciences Limited	ANDA	Current
65841-617	Carvedilol	Carvedilol	Cadila Healthcare Limited	ANDA	Current
65841-618	Carvedilol	Carvedilol	Cadila Healthcare Limited	ANDA	Current
65841-618	Carvedilol	Carvedilol	Cadila Healthcare Limited	ANDA	Current
65841-618	Carvedilol	Carvedilol	Zydus Lifesciences Limited	ANDA	Current
65841-618	Carvedilol	Carvedilol	Cadila Healthcare Limited	ANDA	Current
65841-619	Carvedilol	Carvedilol	Cadila Healthcare Limited	ANDA	Current
65841-619	Carvedilol	Carvedilol	Cadila Healthcare Limited	ANDA	Current
65841-619	Carvedilol	Carvedilol	Zydus Lifesciences Limited	ANDA	Current
65841-619	Carvedilol	Carvedilol	Cadila Healthcare Limited	ANDA	Current
68001-151	Carvedilol	Carvedilol	BluePoint Laboratories	ANDA	Current
68001-151	Carvedilol	Carvedilol	BluePoint Laboratories	ANDA	Current
68001-151	Carvedilol	Carvedilol	BluePoint Laboratories	ANDA	Current
68001-152	Carvedilol	Carvedilol	BluePoint Laboratories	ANDA	Current
68001-152	Carvedilol	Carvedilol	BluePoint Laboratories	ANDA	Current
68001-152	Carvedilol	Carvedilol	BluePoint Laboratories	ANDA	Current
68001-153	Carvedilol	Carvedilol	BluePoint Laboratories	ANDA	Current
68001-153	Carvedilol	Carvedilol	BluePoint Laboratories	ANDA	Current
68001-153	Carvedilol	Carvedilol	BluePoint Laboratories	ANDA	Current
68001-154	Carvedilol	Carvedilol	BluePoint Laboratories	ANDA	Current
68001-154	Carvedilol	Carvedilol	BluePoint Laboratories	ANDA	Current
68001-154	Carvedilol	Carvedilol	BluePoint Laboratories	ANDA	Current
68071-2230	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2230	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2230	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2780	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3138	Carvedilol	Carvedilol	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3138	Carvedilol	Carvedilol	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4956	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4956	Carvedilol	Carvedilol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-843	Carvedilol	Carvedilol	American Health Packaging	ANDA	Current
68084-854	Carvedilol	Carvedilol	American Health Packaging	ANDA	Current
68084-854	Carvedilol	Carvedilol	American Health Packaging	ANDA	Current
68084-854	Carvedilol	Carvedilol	American Health Packaging	ANDA	Current
68084-854	Carvedilol	Carvedilol	American Health Packaging	ANDA	Current
68084-865	Carvedilol	Carvedilol	American Health Packaging	ANDA	Current
68084-876	Carvedilol	Carvedilol	American Health Packaging	ANDA	Current
68382-092	Carvedilol	Carvedilol	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-092	Carvedilol	Carvedilol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-092	Carvedilol	Carvedilol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-093	Carvedilol	Carvedilol	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-093	Carvedilol	Carvedilol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-093	Carvedilol	Carvedilol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-094	Carvedilol	Carvedilol	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-094	Carvedilol	Carvedilol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-094	Carvedilol	Carvedilol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-095	Carvedilol	Carvedilol	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-095	Carvedilol	Carvedilol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-095	Carvedilol	Carvedilol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68645-350	Carvedilol	Carvedilol	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-350	Carvedilol	Carvedilol	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-350	Carvedilol	Carvedilol	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-351	Carvedilol	Carvedilol	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-351	Carvedilol	Carvedilol	Legacy Pharmaceutical Packaging, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31265	ORIG	2007-09-07