Application 078332
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
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 |
|---|---|---|---|---|---|---|---|
| A078332-001 | CARVEDILOL | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | |
| A078332-002 | CARVEDILOL | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | |
| A078332-003 | CARVEDILOL | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | |
| A078332-004 | CARVEDILOL | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078332-001 | AB |
| A078332-002 | AB |
| A078332-003 | AB |
| A078332-004 | 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 | A078332-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078332-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078332-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078332-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078332-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078332-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078332-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078332-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078332-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078332-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078332-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078332-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078332-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078332-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078332-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078332-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078332-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078332-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078332-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078332-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078332-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078332-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078332-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078332-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078332-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078332-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078332-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078332-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078332-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078332-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078332-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078332-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078332-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078332-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078332-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078332-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078332-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078332-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078332-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078332-004 | 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 | A078332-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078332-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078332-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078332-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078332-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078332-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078332-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078332-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078332-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078332-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078332-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078332-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078332-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078332-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078332-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078332-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078332-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078332-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078332-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078332-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078332-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078332-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078332-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078332-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078332-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078332-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078332-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078332-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078332-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078332-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078332-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078332-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078332-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078332-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078332-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078332-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078332-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078332-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078332-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078332-004 | 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 | PD-Rx Pharmaceuticals, Inc. | 0930965b-80e3-4a0c-bffc-14ac32a47894 | 2025-10-17 | Warnings, Adverse reactions | 078332 ANDA078332 43063-833 |
| Carvedilol | CARVEDILOL | PD-Rx Pharmaceuticals, Inc. | 2be8635b-5733-1ed4-e054-00144ff88e88 | 2025-10-15 | Warnings, Adverse reactions | 078332 ANDA078332 43063-125 |
| Carvedilol | CARVEDILOL | PD-Rx Pharmaceuticals, Inc. | 8640adde-d071-44a4-97d0-fa8a8548debe | 2025-10-15 | Warnings, Adverse reactions | 078332 ANDA078332 43063-126 |
| Carvedilol | CARVEDILOL | PD-Rx Pharmaceuticals, Inc. | 205da5d0-05d9-440d-bb5a-b30b826900ab | 2025-10-15 | Warnings, Adverse reactions | 078332 ANDA078332 43063-129 |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | f5969d18-46c7-4f35-9668-2fd4f6bbeb17 | 2025-08-13 | Warnings, Adverse reactions | 078332 ANDA078332 50090-2079 50090-1064 50090-1069 |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | fe4aa7f0-6ef2-4a95-8a64-5e3365f10474 | 2024-07-09 | Warnings, Adverse reactions | 078332 ANDA078332 |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals,Inc. | 786e8ad3-a8d7-41e6-e053-2991aa0a32c7 | 2024-06-12 | Warnings, Adverse reactions | 078332 ANDA078332 |
| Carvedilol | CARVEDILOL | Aurobindo Pharma Limited | 7cc14b86-0833-4c3c-91f3-7963d7052fd5 | 2024-06-07 | Warnings, Adverse reactions | 078332 ANDA078332 |
| Carvedilol | CARVEDILOL | Proficient Rx LP | cd7e7c34-6958-47be-a1c1-f1ed948e2687 | 2022-07-01 | Warnings, Adverse reactions | 078332 ANDA078332 |
| Carvedilol | CARVEDILOL | Proficient Rx LP | 36230cc8-e808-4f74-a27d-4367eecd21f7 | 2022-05-02 | Warnings, Adverse reactions | 078332 ANDA078332 |
| Carvedilol | CARVEDILOL | Proficient Rx LP | 55a19ff1-f8c1-4cf0-8711-9bfa32756de9 | 2020-02-01 | Warnings, Adverse reactions | 078332 ANDA078332 |
| Carvedilol | CARVEDILOL | Aphena Pharma Solutions - Tennessee, LLC | d0089df4-37c8-41de-810c-14c9dc06f0c3 | 2018-09-12 | Warnings, Adverse reactions | 078332 ANDA078332 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-7944 | Carvedilol | Carvedilol | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7944 | Carvedilol | Carvedilol | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7945 | Carvedilol | Carvedilol | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7945 | Carvedilol | Carvedilol | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7946 | Carvedilol | Carvedilol | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7946 | Carvedilol | Carvedilol | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8018 | Carvedilol | Carvedilol | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8018 | Carvedilol | Carvedilol | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-184 | Carvedilol | Carvedilol | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-187 | Carvedilol | Carvedilol | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-190 | Carvedilol | Carvedilol | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-191 | Carvedilol | Carvedilol | Blenheim Pharmacal, Inc. | ANDA | Current |
| 13107-142 | Carvedilol | Carvedilol | Aurolife Pharma LLC | ANDA | Current |
| 13107-143 | Carvedilol | Carvedilol | Aurolife Pharma LLC | ANDA | Current |
| 13107-144 | Carvedilol | Carvedilol | Aurolife Pharma LLC | ANDA | Current |
| 13107-145 | Carvedilol | Carvedilol | Aurolife Pharma LLC | ANDA | Current |
| 33261-975 | Carvedilol | Carvedilol | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-986 | Carvedilol | Carvedilol | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42254-162 | Carvedilol | Carvedilol | Rebel Distributors Corp | ANDA | Current |
| 43063-125 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-125 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-125 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-125 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-125 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-125 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-126 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-126 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-126 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-126 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-126 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-126 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-129 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-129 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-129 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-129 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-129 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-129 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-129 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-129 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-833 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-833 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-833 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-833 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-833 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-833 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-833 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-833 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-833 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-833 | Carvedilol | Carvedilol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-832 | Carvedilol | Carvedilol | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-837 | Carvedilol | Carvedilol | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-838 | Carvedilol | Carvedilol | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-874 | Carvedilol | Carvedilol | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-1064 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-1064 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-1064 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-1069 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-1069 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-1069 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-1856 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-1856 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-1856 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2079 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-2079 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50436-2607 | Carvedilol | Carvedilol | Unit Dose Services | ANDA | Current |
| 52343-026 | Carvedilol | Carvedilol | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-026 | Carvedilol | Carvedilol | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-027 | Carvedilol | Carvedilol | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-027 | Carvedilol | Carvedilol | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-028 | Carvedilol | Carvedilol | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-028 | Carvedilol | Carvedilol | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-029 | Carvedilol | Carvedilol | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-029 | Carvedilol | Carvedilol | ACETRIS HEALTH, LLC | ANDA | Current |
| 53002-1556 | Carvedilol | Carvedilol | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1556 | Carvedilol | Carvedilol | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1572 | Carvedilol | Carvedilol | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1572 | Carvedilol | Carvedilol | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1573 | Carvedilol | Carvedilol | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1573 | Carvedilol | Carvedilol | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1574 | Carvedilol | Carvedilol | RPK Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9144 | ORIG | 2007-09-07 |