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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078240-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078240-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078240-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078240-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078240-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | 2007-10-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078240-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | 2007-10-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078240-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | 2007-10-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078240-004 | CARVEDILOL | 25MG | TABLET / ORAL | 2007-10-30 | 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 | 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 |
| Carvedilol | CARVEDILOL | Coupler LLC | 52bd1d20-08ba-1e5e-e063-6294a90ae8a9 | 2026-05-26 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |
| CARVEDILOL | CARVEDILOL | Bryant Ranch Prepack | 1ddff189-1848-4186-bca9-063e4ea7fd1f | 2026-05-22 | Warnings, Adverse reactions | CARVEDILOL CARVEDILOL |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | d7669550-adcc-4e70-83b1-c28ce75e7fda | 2026-05-21 | Warnings, Adverse reactions | Carvedilol CARVEDILOL |