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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-004 | AB | 1 | d8e5a09893c0… |
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 | Coupler LLC | 58280d18-5960-1730-e063-6394a90a4f64 | 2026-08-03 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | ab8aa773-0ed1-4d59-a1bb-f46cf882644f | 2026-07-30 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 0e98593a-8424-48c8-acc0-671f4b566aee | 2026-07-14 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 32098c09-7580-4975-a3e1-31b619c04c69 | 2026-07-06 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | 196536eb-8b94-45da-a2f3-f554d6bf88e9 | 2026-06-29 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb | 2026-06-26 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 39cf31cc-8f3d-4919-a93a-f997ad6850dc | 2026-06-25 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 6eec3476-f6db-45bd-bb91-4b2d5fbd0f5f | 2026-06-01 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | St. Mary's Medical Park Pharmacy | ed11cd4e-d7c9-8446-e053-2995a90afd6e | 2026-06-01 | Warnings, Adverse reactions | 077614 ANDA077614 60760-582 |
| Carvedilol | CARVEDILOL | Coupler LLC | 52bd1d20-08ba-1e5e-e063-6294a90ae8a9 | 2026-05-26 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Coupler LLC | 51b403dc-fc9f-0cad-e063-6394a90af081 | 2026-05-13 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | QPharma Inc | 010290af-81f4-0037-e063-6394a90a4638 | 2026-05-11 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | St. Mary's Medical Park Pharmacy | 8a82149f-aade-2a9b-e053-2995a90a9daf | 2026-05-05 | Warnings, Adverse reactions | 077614 ANDA077614 60760-494 |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | b23021d4-c00a-e0ef-eb93-1dc824ae56ca | 2026-04-02 | Warnings, Adverse reactions | 077614 ANDA077614 63629-4060 |
| Carvedilol | CARVEDILOL | Preferred Pharmaceuticals, Inc. | 5c34847d-68f9-4967-81c8-a2297a6acb7f | 2026-03-23 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Preferred Pharmaceuticals Inc. | 3b56e0d0-82d7-4512-849f-2b72d7bae36e | 2026-03-20 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | BluePoint Laboratories | e68c9b18-e7fd-45f7-a8f5-1d815e32680b | 2026-03-09 | Warnings, Adverse reactions | 077614 ANDA077614 68001-153 68001-151 68001-152 68001-154 |
| Carvedilol | CARVEDILOL | Direct_Rx | 4c48ba6b-4e1e-5116-e063-6394a90aa793 | 2026-03-05 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Direct_Rx | 4c0e089b-0199-43e2-e063-6394a90a7883 | 2026-03-02 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | 3eb4fd8e-1027-4d24-8f2f-12e9dcfe6231 | 2026-02-13 | Warnings, Adverse reactions | 077614 ANDA077614 |
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 |