Application 077316
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077316-001 | CARVEDILOL | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-09-05 | ||
| A077316-002 | CARVEDILOL | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-09-05 | ||
| A077316-003 | CARVEDILOL | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-09-05 | ||
| A077316-004 | CARVEDILOL | CARVEDILOL | 25MG | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077316-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-09-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077316-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-09-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077316-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-09-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077316-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-09-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077316-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-09-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077316-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-09-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077316-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-09-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077316-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-09-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077316-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-09-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077316-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-09-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077316-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-09-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077316-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-09-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077316-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-09-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077316-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-09-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077316-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-09-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077316-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-09-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077316-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-09-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077316-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-09-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077316-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-09-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077316-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-09-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077316-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-09-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077316-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077316-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077316-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077316-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-09-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077316-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077316-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077316-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077316-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-09-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077316-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077316-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077316-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077316-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-09-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077316-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077316-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077316-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077316-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-09-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077316-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077316-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077316-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077316-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077316-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077316-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077316-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077316-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077316-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077316-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077316-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077316-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077316-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077316-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077316-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077316-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077316-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077316-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077316-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077316-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077316-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077316-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077316-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077316-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077316-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077316-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077316-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077316-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077316-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077316-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077316-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077316-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077316-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077316-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077316-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077316-004 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077316-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077316-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077316-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077316-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077316-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077316-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077316-003 | AB | 1 | 5d02ea3f76ae… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Carvedilol | CARVEDILOL | Teva Pharmaceuticals USA, Inc. | 68c275e8-992a-4520-8065-ab6d615d89cc | 2024-03-25 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals, Inc. | 49afdf89-0bed-71da-e054-00144ff88e88 | 2024-01-12 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | e0ae5bed-1cb4-45d6-befe-dfc68edb9b34 | 2023-12-05 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Proficient Rx LP | cd7e7c34-6958-47be-a1c1-f1ed948e2687 | 2022-07-01 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Proficient Rx LP | 36230cc8-e808-4f74-a27d-4367eecd21f7 | 2022-05-02 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Proficient Rx LP | c03bd9d7-1e0b-49da-a14a-32e712dc3a2d | 2021-05-01 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Proficient Rx LP | 55a19ff1-f8c1-4cf0-8711-9bfa32756de9 | 2020-02-01 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Dr. Reddy's Laboratories Limited | 1e453c21-a8a8-dc54-5591-74c972d41727 | 2018-12-05 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Aphena Pharma Solutions - Tennessee, LLC | d0089df4-37c8-41de-810c-14c9dc06f0c3 | 2018-09-12 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Aphena Pharma Solutions - Tennessee, LLC | e3f463b5-2743-4a4a-a90a-bf1ee10a5458 | 2018-05-29 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-3631 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3631 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3631 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3631 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3631 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3632 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3632 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3632 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3632 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3632 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3633 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3633 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3633 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3633 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3633 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3634 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3634 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3634 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3634 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3634 | Carvedilol | carvedilol | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 43353-132 | Carvedilol | carvedilol | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-133 | Carvedilol | carvedilol | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-156 | Carvedilol | carvedilol | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-160 | Carvedilol | carvedilol | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 51079-771 | Carvedilol | carvedilol | Mylan Institutional Inc. | ANDA | Current |
| 51079-771 | Carvedilol | carvedilol | Mylan Institutional Inc. | ANDA | Current |
| 51079-771 | Carvedilol | carvedilol | Mylan Institutional Inc. | ANDA | Current |
| 51079-930 | Carvedilol | carvedilol | Mylan Institutional Inc. | ANDA | Current |
| 51079-930 | Carvedilol | carvedilol | Mylan Institutional Inc. | ANDA | Current |
| 51079-930 | Carvedilol | carvedilol | Mylan Institutional Inc. | ANDA | Current |
| 51079-931 | Carvedilol | carvedilol | Mylan Institutional Inc. | ANDA | Current |
| 51079-931 | Carvedilol | carvedilol | Mylan Institutional Inc. | ANDA | Current |
| 51079-931 | Carvedilol | carvedilol | Mylan Institutional Inc. | ANDA | Current |
| 51079-932 | Carvedilol | carvedilol | Mylan Institutional Inc. | ANDA | Current |
| 51079-932 | Carvedilol | carvedilol | Mylan Institutional Inc. | ANDA | Current |
| 51079-932 | Carvedilol | carvedilol | Mylan Institutional Inc. | ANDA | Current |
| 51655-002 | Carvedilol | Carvedilol | Northwind Pharmaceuticals | ANDA | Current |
| 55154-5675 | Carvedilol | carvedilol | Cardinal Health 107, LLC | ANDA | Current |
| 55154-5675 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5675 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5675 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5675 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5675 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5676 | Carvedilol | carvedilol | Cardinal Health 107, LLC | ANDA | Current |
| 55154-5676 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5676 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5676 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5676 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5676 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5677 | Carvedilol | carvedilol | Cardinal Health 107, LLC | ANDA | Current |
| 55154-5677 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5677 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5677 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5677 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5677 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5678 | Carvedilol | carvedilol | Cardinal Health 107, LLC | ANDA | Current |
| 55154-5678 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5678 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5678 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5678 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
| 55154-5678 | Carvedilol | carvedilol | Cardinal Health | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31222 | ORIG | 2007-09-07 |