Application 077614
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 6.25MG | No | No |
| 002 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 12.5MG | No | No |
| 003 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 25MG | No | No |
| 004 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 3.125MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077614-001 | CARVEDILOL | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | |
| A077614-002 | CARVEDILOL | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | |
| A077614-003 | CARVEDILOL | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | |
| A077614-004 | CARVEDILOL | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077614-001 | AB |
| A077614-002 | AB |
| A077614-003 | AB |
| A077614-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077614-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077614-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077614-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077614-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A077614-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077614-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077614-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077614-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-004 | AB | 1 | 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 | NuCare Pharmaceuticals,Inc. | ac14846e-423a-37c4-e053-2a95a90a3cdd | 2025-01-02 | Warnings, Adverse reactions | 077614 ANDA077614 68071-2230 |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | da830b08-1cdd-4d36-a068-c376fd7763c4 | 2024-08-22 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Proficient Rx LP | 0bfea06d-7abe-407a-80a4-d15d373569f7 | 2024-07-01 | Warnings, Adverse reactions | 077614 ANDA077614 63187-570 |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals,Inc. | e31271aa-259b-caa6-e053-2995a90a0fcd | 2024-06-28 | Warnings, Adverse reactions | 077614 ANDA077614 68071-2780 |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals,Inc. | 8ccf07f5-78fb-76da-e053-2a95a90a0090 | 2024-06-18 | Warnings, Adverse reactions | 077614 ANDA077614 68071-4956 |
| Carvedilol | CARVEDILOL | NuCare Pharmaceuticals, Inc. | 49afdf89-0bed-71da-e054-00144ff88e88 | 2024-01-12 | Warnings, Adverse reactions | 077614 ANDA077614 68071-3138 |
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 |
|---|---|---|---|---|---|
| 50090-4171 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 50090-4171 | Carvedilol | Carvedilol | A-S Medication Solutions | ANDA | Current |
| 51655-029 | CARVEDILOL | CARVEDILOL | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-030 | Carvedilol | Carvedilol | Northwind Pharmaceuticals | ANDA | Current |
| 51655-397 | Carvedilol | Carvedilol | Northwind Pharmaceuticals | ANDA | Current |
| 51655-397 | Carvedilol | Carvedilol | Northwind Pharmaceuticals | ANDA | Current |
| 52959-466 | Carvedilol | Carvedilol | H.J. Harkins Company, Inc. | ANDA | Current |
| 53808-0220 | Carvedilol | Carvedilol | State of Florida DOH Central Pharmacy | ANDA | Current |
| 60760-494 | Carvedilol | Carvedilol | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-582 | Carvedilol | Carvedilol | ST. MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 63187-424 | Carvedilol | Carvedilol | Proficient Rx LP | ANDA | Current |
| 63187-424 | Carvedilol | Carvedilol | Proficient Rx LP | ANDA | Current |
| 63187-570 | Carvedilol | Carvedilol | Proficient Rx LP | ANDA | Current |
| 63187-570 | Carvedilol | Carvedilol | Proficient Rx LP | ANDA | Current |
| 63629-4060 | Carvedilol | Carvedilol | Bryant Ranch Prepack | ANDA | Current |
| 63629-4060 | Carvedilol | Carvedilol | Bryant Ranch Prepack | ANDA | Current |
| 63629-4060 | Carvedilol | Carvedilol | Bryant Ranch Prepack | ANDA | Current |
| 63629-4070 | Carvedilol | Carvedilol | Bryant Ranch Prepack | ANDA | Current |
| 63629-8039 | Carvedilol | Carvedilol | Bryant Ranch Prepack | ANDA | Current |
| 63629-8039 | Carvedilol | Carvedilol | Bryant Ranch Prepack | ANDA | Current |
| 65841-616 | Carvedilol | Carvedilol | Cadila Healthcare Limited | ANDA | Current |
| 65841-616 | Carvedilol | Carvedilol | Cadila Healthcare Limited | ANDA | Current |
| 65841-616 | Carvedilol | Carvedilol | Zydus Lifesciences Limited | ANDA | Current |
| 65841-616 | Carvedilol | Carvedilol | Cadila Healthcare Limited | ANDA | Current |
| 65841-617 | Carvedilol | Carvedilol | Cadila Healthcare Limited | ANDA | Current |
| 65841-617 | Carvedilol | Carvedilol | Cadila Healthcare Limited | ANDA | Current |
| 65841-617 | Carvedilol | Carvedilol | Zydus Lifesciences Limited | ANDA | Current |
| 65841-617 | Carvedilol | Carvedilol | Cadila Healthcare Limited | ANDA | Current |
| 65841-618 | Carvedilol | Carvedilol | Cadila Healthcare Limited | ANDA | Current |
| 65841-618 | Carvedilol | Carvedilol | Cadila Healthcare Limited | ANDA | Current |
| 65841-618 | Carvedilol | Carvedilol | Zydus Lifesciences Limited | ANDA | Current |
| 65841-618 | Carvedilol | Carvedilol | Cadila Healthcare Limited | ANDA | Current |
| 65841-619 | Carvedilol | Carvedilol | Cadila Healthcare Limited | ANDA | Current |
| 65841-619 | Carvedilol | Carvedilol | Cadila Healthcare Limited | ANDA | Current |
| 65841-619 | Carvedilol | Carvedilol | Zydus Lifesciences Limited | ANDA | Current |
| 65841-619 | Carvedilol | Carvedilol | Cadila Healthcare Limited | ANDA | Current |
| 68001-151 | Carvedilol | Carvedilol | BluePoint Laboratories | ANDA | Current |
| 68001-151 | Carvedilol | Carvedilol | BluePoint Laboratories | ANDA | Current |
| 68001-151 | Carvedilol | Carvedilol | BluePoint Laboratories | ANDA | Current |
| 68001-152 | Carvedilol | Carvedilol | BluePoint Laboratories | ANDA | Current |
| 68001-152 | Carvedilol | Carvedilol | BluePoint Laboratories | ANDA | Current |
| 68001-152 | Carvedilol | Carvedilol | BluePoint Laboratories | ANDA | Current |
| 68001-153 | Carvedilol | Carvedilol | BluePoint Laboratories | ANDA | Current |
| 68001-153 | Carvedilol | Carvedilol | BluePoint Laboratories | ANDA | Current |
| 68001-153 | Carvedilol | Carvedilol | BluePoint Laboratories | ANDA | Current |
| 68001-154 | Carvedilol | Carvedilol | BluePoint Laboratories | ANDA | Current |
| 68001-154 | Carvedilol | Carvedilol | BluePoint Laboratories | ANDA | Current |
| 68001-154 | Carvedilol | Carvedilol | BluePoint Laboratories | ANDA | Current |
| 68071-2230 | Carvedilol | Carvedilol | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2230 | Carvedilol | Carvedilol | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2230 | Carvedilol | Carvedilol | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2780 | Carvedilol | Carvedilol | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3138 | Carvedilol | Carvedilol | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3138 | Carvedilol | Carvedilol | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4956 | Carvedilol | Carvedilol | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4956 | Carvedilol | Carvedilol | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-843 | Carvedilol | Carvedilol | American Health Packaging | ANDA | Current |
| 68084-854 | Carvedilol | Carvedilol | American Health Packaging | ANDA | Current |
| 68084-854 | Carvedilol | Carvedilol | American Health Packaging | ANDA | Current |
| 68084-854 | Carvedilol | Carvedilol | American Health Packaging | ANDA | Current |
| 68084-854 | Carvedilol | Carvedilol | American Health Packaging | ANDA | Current |
| 68084-865 | Carvedilol | Carvedilol | American Health Packaging | ANDA | Current |
| 68084-876 | Carvedilol | Carvedilol | American Health Packaging | ANDA | Current |
| 68382-092 | Carvedilol | Carvedilol | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-092 | Carvedilol | Carvedilol | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-092 | Carvedilol | Carvedilol | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-093 | Carvedilol | Carvedilol | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-093 | Carvedilol | Carvedilol | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-093 | Carvedilol | Carvedilol | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-094 | Carvedilol | Carvedilol | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-094 | Carvedilol | Carvedilol | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-094 | Carvedilol | Carvedilol | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-095 | Carvedilol | Carvedilol | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-095 | Carvedilol | Carvedilol | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-095 | Carvedilol | Carvedilol | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68645-350 | Carvedilol | Carvedilol | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-350 | Carvedilol | Carvedilol | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-350 | Carvedilol | Carvedilol | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-351 | Carvedilol | Carvedilol | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-351 | Carvedilol | Carvedilol | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31265 | ORIG | 2007-09-07 |