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 | St. Mary's Medical Park Pharmacy | ed11cd4e-d7c9-8446-e053-2995a90afd6e | 2026-06-01 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| CARVEDILOL | CARVEDILOL | Bryant Ranch Prepack | 03b7c07c-14ba-40c8-8c0a-8dfa4a10f580 | 2026-05-27 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| CARVEDILOL | CARVEDILOL | Bryant Ranch Prepack | fe462198-32ae-4f6c-befc-acb97fb017c9 | 2026-05-27 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| Carvedilol | CARVEDILOL | Coupler LLC | 52bd1d20-08ba-1e5e-e063-6294a90ae8a9 | 2026-05-26 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| CARVEDILOL | CARVEDILOL | Bryant Ranch Prepack | 1ddff189-1848-4186-bca9-063e4ea7fd1f | 2026-05-22 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | d7669550-adcc-4e70-83b1-c28ce75e7fda | 2026-05-21 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | 21191d89-16f6-49a8-9394-f31d0950deea | 2026-05-20 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Coupler LLC | 51b403dc-fc9f-0cad-e063-6394a90af081 | 2026-05-13 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | QPharma Inc | 010290af-81f4-0037-e063-6394a90a4638 | 2026-05-11 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | 7aae1a4a-5d0e-4b19-9e4c-55707a9bb184 | 2026-05-11 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | fe2d5c95-c101-4b01-89fd-0fd6d25ad80b | 2026-04-26 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Cardinal Health 107, LLC | bd0f2596-a192-4b0e-836f-4a09816408a4 | 2026-04-16 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | b23021d4-c00a-e0ef-eb93-1dc824ae56ca | 2026-04-02 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Preferred Pharmaceuticals, Inc. | 5c34847d-68f9-4967-81c8-a2297a6acb7f | 2026-03-23 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Preferred Pharmaceuticals Inc. | 3b56e0d0-82d7-4512-849f-2b72d7bae36e | 2026-03-20 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | BluePoint Laboratories | e68c9b18-e7fd-45f7-a8f5-1d815e32680b | 2026-03-09 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Direct_Rx | 4c48ba6b-4e1e-5116-e063-6394a90aa793 | 2026-03-05 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Direct_Rx | 4c0e089b-0199-43e2-e063-6394a90a7883 | 2026-03-02 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Proficient Rx LP | 8db9cddd-0ee7-4ce8-a8c9-c5e043b2838a | 2026-03-01 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| CARVEDILOL | CARVEDILOL | NuCare Pharmaceuticals, Inc. | 4bbf3767-8666-22d8-e063-6294a90a2afe | 2026-02-26 | 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 |