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 1 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	d7d6bfff-fbb6-4a1f-aa13-babbb9a1e878	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	St. Mary's Medical Park Pharmacy	8a82149f-aade-2a9b-e053-2995a90a9daf	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	c5b907f8-84a0-5fb2-e7ec-4c82246195f5	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Coupler LLC	58280d18-5960-1730-e063-6394a90a4f64	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	ab8aa773-0ed1-4d59-a1bb-f46cf882644f	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 70518-2389
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	0e98593a-8424-48c8-acc0-671f4b566aee	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 70518-1826
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	32098c09-7580-4975-a3e1-31b619c04c69	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 70518-1377
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	196536eb-8b94-45da-a2f3-f554d6bf88e9	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 71335-1545 ndc (product): 71335-1623
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 70518-0426
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	39cf31cc-8f3d-4919-a93a-f997ad6850dc	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 70518-0356
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	6eec3476-f6db-45bd-bb91-4b2d5fbd0f5f	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 70518-0840
Carvedilol	CARVEDILOL	St. Mary's Medical Park Pharmacy	ed11cd4e-d7c9-8446-e053-2995a90afd6e	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Coupler LLC	52bd1d20-08ba-1e5e-e063-6294a90ae8a9	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Coupler LLC	51b403dc-fc9f-0cad-e063-6394a90af081	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	QPharma Inc	010290af-81f4-0037-e063-6394a90a4638	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	b23021d4-c00a-e0ef-eb93-1dc824ae56ca	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Preferred Pharmaceuticals, Inc.	5c34847d-68f9-4967-81c8-a2297a6acb7f	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 68788-7539
Carvedilol	CARVEDILOL	Preferred Pharmaceuticals Inc.	3b56e0d0-82d7-4512-849f-2b72d7bae36e	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614 ndc (product): 68788-8252
Carvedilol	CARVEDILOL	BluePoint Laboratories	e68c9b18-e7fd-45f7-a8f5-1d815e32680b	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Direct_Rx	4c48ba6b-4e1e-5116-e063-6394a90aa793	2026-03-05	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 2 of 2 · 144 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68645-351	Carvedilol	Carvedilol	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-496	Carvedilol	Carvedilol	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-496	Carvedilol	Carvedilol	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-496	Carvedilol	Carvedilol	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68788-7539	Carvedilol	Carvedilol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7539	Carvedilol	Carvedilol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7539	Carvedilol	Carvedilol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7539	Carvedilol	Carvedilol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8252	Carvedilol	Carvedilol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9265	Carvedilol	Carvedilol	Preferred Pharmaceuticals,Inc.	ANDA	Current
68788-9265	Carvedilol	Carvedilol	Preferred Pharmaceuticals,Inc.	ANDA	Current
68788-9265	Carvedilol	Carvedilol	Preferred Pharmaceuticals,Inc.	ANDA	Current
68788-9265	Carvedilol	Carvedilol	Preferred Pharmaceuticals,Inc.	ANDA	Current
68788-9265	Carvedilol	Carvedilol	Preferred Pharmaceuticals,Inc.	ANDA	Current
68788-9789	Carvedilol	Carvedilol	Preferred Pharmaceuticals,Inc.	ANDA	Current
68788-9789	Carvedilol	Carvedilol	Preferred Pharmaceuticals,Inc.	ANDA	Current
68788-9789	Carvedilol	Carvedilol	Preferred Pharmaceuticals,Inc.	ANDA	Current
68788-9789	Carvedilol	Carvedilol	Preferred Pharmaceuticals,Inc.	ANDA	Current
68788-9789	Carvedilol	Carvedilol	Preferred Pharmaceuticals,Inc.	ANDA	Current
70518-0356	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0356	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0356	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0356	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0356	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0356	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0356	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0426	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0426	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0426	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0426	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0426	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0426	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0582	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0582	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0582	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0582	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0582	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0840	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0840	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-0840	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1377	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1377	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1377	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1377	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1377	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1377	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1377	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1377	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1826	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1826	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1826	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-1826	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-2389	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-2389	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70518-2389	Carvedilol	Carvedilol	REMEDYREPACK INC.	ANDA	Current
70934-211	Carvedilol	Carvedilol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-211	Carvedilol	Carvedilol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-211	Carvedilol	Carvedilol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-759	Carvedilol	Carvedilol	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-759	Carvedilol	Carvedilol	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71335-1545	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
71335-1545	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
71335-1623	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current
71335-2101	Carvedilol	Carvedilol	Bryant Ranch Prepack	ANDA	Current

Documents#

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