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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077316-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-09-05 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077316-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077316-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077316-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… |
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 | Redpharm Drug | 58337744-a130-35ef-e063-6294a90a080b | 2026-08-04 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Coupler LLC | 58280d18-5960-1730-e063-6394a90a4f64 | 2026-08-03 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Coreg | CARVEDILOL | Waylis Therapeutics LLC | 07c619c6-4a0c-445e-94fa-664a54f68a39 | 2026-07-31 | Warnings, Adverse reactions | CARVEDILOL |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | ab8aa773-0ed1-4d59-a1bb-f46cf882644f | 2026-07-30 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| CARVEDILOL | CARVEDILOL | PD-Rx Pharmaceuticals, Inc. | 95300809-be15-461e-904e-b56aba676975 | 2026-07-29 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| CARVEDILOL | CARVEDILOL | PD-Rx Pharmaceuticals, Inc. | 9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa9 | 2026-07-29 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| CARVEDILOL | CARVEDILOL | NuCare Pharmaceuticals, Inc. | 574c419f-3b9e-2171-e063-6394a90a0e90 | 2026-07-23 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 0e98593a-8424-48c8-acc0-671f4b566aee | 2026-07-14 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 32098c09-7580-4975-a3e1-31b619c04c69 | 2026-07-06 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | 196536eb-8b94-45da-a2f3-f554d6bf88e9 | 2026-06-29 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb | 2026-06-26 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 39cf31cc-8f3d-4919-a93a-f997ad6850dc | 2026-06-25 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | cc3a9614-3017-4775-988e-6e5bd4621b70 | 2026-06-18 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | 45233e64-26ee-4117-a896-24363b435fc2 | 2026-06-18 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Major Pharmaceuticals | ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e | 2026-06-15 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | b4e700f8-d0e0-4ad5-93b5-e935389a96e3 | 2026-06-05 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 6eec3476-f6db-45bd-bb91-4b2d5fbd0f5f | 2026-06-01 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| 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 |
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 |