Application 078240
- Type
- ANDA
- Sponsor
- PLIVA HRVATSKA DOO
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 |
|---|---|---|---|---|---|---|---|
| A078240-001 | CARVEDILOL | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | ||
| A078240-002 | CARVEDILOL | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | ||
| A078240-003 | CARVEDILOL | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | ||
| A078240-004 | CARVEDILOL | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 |
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 | A078240-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078240-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078240-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078240-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078240-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078240-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078240-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078240-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078240-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078240-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078240-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078240-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078240-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078240-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078240-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078240-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078240-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078240-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078240-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078240-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078240-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078240-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078240-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078240-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078240-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078240-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078240-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078240-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078240-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078240-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078240-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078240-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078240-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078240-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078240-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078240-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078240-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078240-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078240-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078240-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 | 5bbf6a4d5a75… |
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 | A-S Medication Solutions | f5969d18-46c7-4f35-9668-2fd4f6bbeb17 | 2025-08-13 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | NCS HealthCare of KY, LLC dba Vangard Labs | 2fb46fe1-9b7b-4718-9327-2471af22f0b7 | 2025-06-11 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Proficient Rx LP | da2696ba-f4be-4626-9abe-fe33f36361b1 | 2025-05-01 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Proficient Rx LP | a1344411-fc64-4233-89ba-e90a1953e150 | 2025-03-01 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | American Health Packaging | a97a2467-7525-467c-8969-38246903690c | 2025-02-20 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Preferred Pharmaceuticals,Inc. | 81bc612d-5674-45b9-a1f5-2cb4fa625747 | 2025-02-14 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| CARVEDILOL | CARVEDILOL | Preferred Pharmaceuticals Inc. | 8d3937b4-e0dd-4165-9825-bbf5020d79f9 | 2025-02-14 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| Carvedilol | CARVEDILOL | Proficient Rx LP | c0202d0f-2ffc-45f2-a98d-5f05ac1eaa85 | 2025-02-01 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| CARVEDILOL | CARVEDILOL | RedPharm Drug, Inc | fcb1de7c-1878-1835-e053-6294a90abe95 | 2025-01-23 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| CARVEDILOL | CARVEDILOL | RedPharm Drug, Inc | fcb2025f-11a1-ea73-e053-6394a90a61cb | 2025-01-23 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| Carvedilol | CARVEDILOL | Direct_Rx | e5e766e3-ef75-4100-e053-2995a90a510f | 2025-01-22 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals,Inc. | ac14846e-423a-37c4-e053-2a95a90a3cdd | 2025-01-02 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | da830b08-1cdd-4d36-a068-c376fd7763c4 | 2024-08-22 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals,Inc. | a7bfd0fc-054b-7397-e053-2a95a90ae3e2 | 2024-07-17 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | fe4aa7f0-6ef2-4a95-8a64-5e3365f10474 | 2024-07-09 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Proficient Rx LP | 0bfea06d-7abe-407a-80a4-d15d373569f7 | 2024-07-01 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals,Inc. | e31271aa-259b-caa6-e053-2995a90a0fcd | 2024-06-28 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals,Inc. | 8ccf07f5-78fb-76da-e053-2a95a90a0090 | 2024-06-18 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals,Inc. | 786e8ad3-a8d7-41e6-e053-2991aa0a32c7 | 2024-06-12 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| Carvedilol | CARVEDILOL | Aurobindo Pharma Limited | 7cc14b86-0833-4c3c-91f3-7963d7052fd5 | 2024-06-07 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.