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 | NuCare Pharmaceuticals,Inc. | e285434f-d831-b6e7-e053-2995a90a1ab2 | 2026-02-26 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals,Inc. | 84ee5fbf-7299-4b8a-e053-2a91aa0aa159 | 2026-02-25 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Advagen Pharma Limited | 205291ba-86a7-43e1-be47-bc75df1921f9 | 2026-02-23 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| CARVEDILOL | CARVEDILOL | Advagen Pharma Ltd | 7a7d3ca1-05b0-4c7e-aefa-492cc441585d | 2026-02-23 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | 3eb4fd8e-1027-4d24-8f2f-12e9dcfe6231 | 2026-02-13 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | add1ee3d-fca4-4301-b871-7dda6eda7bb7 | 2026-02-13 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Golden State Medical Supply, Inc. | 454054f1-0730-41b3-844a-c7b65f1b47c5 | 2026-02-11 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | 3724c7f1-dd2a-4bc9-b388-17238d663860 | 2026-02-03 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | 157f64c6-2c21-4056-b643-79047ca237a9 | 2026-02-03 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | UNICHEM PHARMACEUTICALS (USA), INC. | 33dfcf29-19d6-46ba-b8ed-d59d2226ad07 | 2026-01-23 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | ee848543-12fb-446c-86db-bf2322ec986f | 2026-01-23 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | PD-Rx Pharmaceuticals, Inc. | 444ee05c-571a-4ea6-8763-af05d252df56 | 2026-01-20 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | f0617fa4-1e87-48fa-947a-e4249153a947 | 2026-01-20 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | 3c8d54e6-835c-4fa7-b13b-b798916cfed3 | 2026-01-20 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | dd8b2a3f-c2fa-4859-84a1-c02f2b608748 | 2026-01-20 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| CARVEDILOL | CARVEDILOL | A-S Medication Solutions | 5eeeaeee-9698-493f-9aa7-d13068147208 | 2026-01-08 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| CARVEDILOL | CARVEDILOL | A-S Medication Solutions | 947baca7-f9c8-4821-b47b-53c45288613e | 2026-01-08 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| Carvedilol | CARVEDILOL | Quallent Pharmaceuticals Health LLC | eb892787-edd0-4ab6-aef2-2d0216384395 | 2026-01-03 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Northwind Health Company, LLC | df7415ac-e475-19c9-e053-2995a90afa71 | 2026-01-01 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Northwind Health Company, LLC | b0887c72-bc6a-010d-e053-2995a90aab8d | 2026-01-01 | 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 |