Application 078251
- Type
- ANDA
- Sponsor
- GLENMARK GENERICS
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 |
|---|---|---|---|---|---|---|---|
| A078251-001 | CARVEDILOL | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | |
| A078251-002 | CARVEDILOL | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | |
| A078251-003 | CARVEDILOL | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | |
| A078251-004 | CARVEDILOL | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078251-001 | AB |
| A078251-002 | AB |
| A078251-003 | AB |
| A078251-004 | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078251-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078251-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078251-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078251-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078251-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078251-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078251-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078251-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078251-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078251-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078251-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078251-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078251-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078251-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078251-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078251-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078251-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078251-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078251-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078251-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078251-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078251-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078251-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078251-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078251-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078251-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078251-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078251-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078251-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078251-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078251-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078251-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078251-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078251-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078251-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078251-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078251-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078251-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078251-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078251-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078251-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078251-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078251-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078251-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078251-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078251-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078251-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078251-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078251-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078251-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078251-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078251-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078251-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078251-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078251-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078251-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078251-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078251-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078251-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078251-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078251-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078251-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078251-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078251-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078251-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078251-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078251-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078251-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078251-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078251-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078251-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078251-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078251-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078251-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078251-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078251-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078251-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078251-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078251-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078251-004 | AB | 1 | d06236e962d9… |
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 | Major Pharmaceuticals | ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e | 2026-06-15 | Warnings, Adverse reactions | 078251 ANDA078251 |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | b4e700f8-d0e0-4ad5-93b5-e935389a96e3 | 2026-06-05 | Warnings, Adverse reactions | 078251 ANDA078251 71335-1128 |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | d7669550-adcc-4e70-83b1-c28ce75e7fda | 2026-05-21 | Warnings, Adverse reactions | 078251 ANDA078251 |
| Carvedilol | CARVEDILOL | Cardinal Health 107, LLC | bd0f2596-a192-4b0e-836f-4a09816408a4 | 2026-04-16 | Warnings, Adverse reactions | 078251 ANDA078251 |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals,Inc. | e285434f-d831-b6e7-e053-2995a90a1ab2 | 2026-02-26 | Warnings, Adverse reactions | 078251 ANDA078251 68071-2773 |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals,Inc. | 84ee5fbf-7299-4b8a-e053-2a91aa0aa159 | 2026-02-25 | Warnings, Adverse reactions | 078251 ANDA078251 68071-4816 |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | ee848543-12fb-446c-86db-bf2322ec986f | 2026-01-23 | Warnings, Adverse reactions | 078251 ANDA078251 50090-2066 50090-2555 50090-2119 50090-2175 |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | 3c8d54e6-835c-4fa7-b13b-b798916cfed3 | 2026-01-20 | Warnings, Adverse reactions | 078251 ANDA078251 50090-4898 |
| Carvedilol | CARVEDILOL | Northwind Health Company, LLC | c133b9c7-ab1a-e517-e053-2995a90a517a | 2026-01-01 | Warnings, Adverse reactions | 078251 ANDA078251 51655-033 |
| Carvedilol | CARVEDILOL | Glenmark Pharmaceuticals Inc., USA | c4a21f67-7812-4634-beba-f8e85c63c5f2 | 2025-10-27 | Warnings, Adverse reactions | 078251 ANDA078251 68462-164 68462-165 68462-163 68462-162 |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | e0ae5bed-1cb4-45d6-befe-dfc68edb9b34 | 2023-12-05 | Warnings, Adverse reactions | 078251 ANDA078251 |
| Carvedilol | CARVEDILOL | Proficient Rx LP | c03bd9d7-1e0b-49da-a14a-32e712dc3a2d | 2021-05-01 | Warnings, Adverse reactions | 078251 ANDA078251 63187-131 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 33261-537 | Carvedilol | Carvedilol | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-848 | Carvedilol | Carvedilol | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 35356-512 | Carvedilol | Carvedilol | Lake Erie Medical DBA Qua | ANDA | Current |
| 35356-512 | Carvedilol | Carvedilol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-512 | Carvedilol | Carvedilol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-512 | Carvedilol | Carvedilol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-512 | Carvedilol | Carvedilol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-526 | Carvedilol | Carvedilol | Lake Erie Medical DBA Qua | ANDA | Current |
| 35356-526 | Carvedilol | Carvedilol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-526 | Carvedilol | Carvedilol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-526 | Carvedilol | Carvedilol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-526 | Carvedilol | Carvedilol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-526 | Carvedilol | Carvedilol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-526 | Carvedilol | Carvedilol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-908 | Carvedilol | Carvedilol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-2066 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2066 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2066 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2066 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2119 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2119 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2119 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2119 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2119 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2175 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2175 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2175 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2555 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2555 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2555 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2555 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-4898 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 51655-033 | Carvedilol | Carvedilol | Northwind Pharmaceuticals | ANDA | Current |
| 51655-033 | Carvedilol | Carvedilol | Northwind Pharmaceuticals | ANDA | Current |
| 52959-204 | Carvedilol | Carvedilol | H.J. Harkins Company, Inc. | ANDA | Current |
| 53808-0218 | Carvedilol | Carvedilol | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0219 | Carvedilol | Carvedilol | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0221 | Carvedilol | Carvedilol | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0603 | Carvedilol | Carvedilol | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55700-322 | Carvedilol | Carvedilol | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 58118-0163 | Carvedilol | Carvedilol | Clinical Solutions Wholesale | ANDA | Current |
| 58118-0163 | Carvedilol | Carvedilol | Clinical Solutions Wholesale | ANDA | Current |
| 58118-0163 | Carvedilol | Carvedilol | Clinical Solutions Wholesale | ANDA | Current |
| 60760-532 | Carvedilol | Carvedilol | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-532 | Carvedilol | Carvedilol | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63187-131 | Carvedilol | Carvedilol | Proficient Rx LP | ANDA | Current |
| 63187-131 | Carvedilol | Carvedilol | Proficient Rx LP | ANDA | Current |
| 63187-131 | Carvedilol | Carvedilol | Proficient Rx LP | ANDA | Current |
| 67296-0681 | Carvedilol | Carvedilol | RedPharm Drug Inc. | ANDA | Current |
| 68071-2773 | Carvedilol | Carvedilol | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4816 | Carvedilol | Carvedilol | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4980 | Carvedilol | Carvedilol | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4980 | Carvedilol | Carvedilol | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68462-162 | Carvedilol | Carvedilol | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-162 | Carvedilol | Carvedilol | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-163 | Carvedilol | Carvedilol | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-163 | Carvedilol | Carvedilol | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-164 | Carvedilol | Carvedilol | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-164 | Carvedilol | Carvedilol | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-165 | Carvedilol | Carvedilol | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-165 | Carvedilol | Carvedilol | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68788-7458 | Carvedilol | Carvedilol | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7458 | Carvedilol | Carvedilol | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7458 | Carvedilol | Carvedilol | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7458 | Carvedilol | Carvedilol | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7603 | Carvedilol | Carvedilol | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7603 | Carvedilol | Carvedilol | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7603 | Carvedilol | Carvedilol | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7910 | Carvedilol | Carvedilol | Preferred Pharmaceuticals Inc., | ANDA | Current |
| 68788-8151 | Carvedilol | Carvedilol | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0095 | Carvedilol | Carvedilol | REMEDYREPACK INC. | ANDA | Current |
| 70518-0095 | Carvedilol | Carvedilol | REMEDYREPACK INC. | ANDA | Current |
| 70518-0095 | Carvedilol | Carvedilol | REMEDYREPACK INC. | ANDA | Current |
| 70934-609 | Carvedilol | Carvedilol | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-686 | Carvedilol | Carvedilol | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-707 | Carvedilol | Carvedilol | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-707 | Carvedilol | Carvedilol | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-753 | Carvedilol | Carvedilol | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-753 | Carvedilol | Carvedilol | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71335-1128 | Carvedilol | Carvedilol | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31350 | ORIG | 2007-09-07 |