Application 207616
- Type
- ANDA
- Sponsor
- HETERO LABS LTD V
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 5MG | No | No |
| 002 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 10MG | No | No |
| 003 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 20MG | No | No |
| 004 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207616-001 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | |
| A207616-002 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | |
| A207616-003 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | |
| A207616-004 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207616-001 | AB |
| A207616-002 | AB |
| A207616-003 | AB |
| A207616-004 | 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 | A207616-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207616-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207616-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207616-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207616-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207616-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207616-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207616-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207616-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207616-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207616-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207616-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207616-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207616-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207616-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207616-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207616-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207616-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207616-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207616-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207616-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207616-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207616-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207616-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207616-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207616-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207616-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207616-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207616-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207616-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207616-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207616-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207616-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207616-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207616-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207616-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207616-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207616-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207616-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207616-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 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 | A207616-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207616-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207616-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207616-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207616-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207616-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207616-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207616-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207616-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207616-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207616-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207616-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207616-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207616-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207616-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207616-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207616-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207616-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207616-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207616-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207616-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207616-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207616-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207616-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207616-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207616-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207616-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207616-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207616-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207616-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207616-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207616-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207616-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207616-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207616-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207616-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207616-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207616-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207616-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207616-004 | 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 |
|---|---|---|---|---|---|---|
| Rosuvastatin | ROSUVASTATIN | Camber Pharmaceuticals, Inc. | 7778df5a-82c1-4a86-8867-a3325da025ec | 2026-06-17 | Warnings, Adverse reactions | 207616 ANDA207616 31722-883 31722-884 31722-882 31722-885 |
| Rosuvastatin | ROSUVASTATIN | Cardinal Health 107, LLC | 0f7fad2c-fc46-4ebc-b55b-6534da99e053 | 2026-06-12 | Warnings, Adverse reactions | 207616 ANDA207616 |
| Rosuvastatin | ROSUVASTATIN | Bryant Ranch Prepack | e6b86b67-62c7-43cc-8174-b2b8e0a60711 | 2026-04-13 | Warnings, Adverse reactions | 207616 ANDA207616 |
| Rosuvastatin | ROSUVASTATIN | Preferred Pharmaceuticals Inc. | 979588e5-d266-4728-aa58-36cd6a217584 | 2025-09-18 | Warnings, Adverse reactions | 207616 ANDA207616 |
| Rosuvastatin | ROSUVASTATIN | Preferred Pharmaceuticals Inc. | 92a58577-b549-4143-abd0-391a07ed714d | 2025-09-18 | Warnings, Adverse reactions | 207616 ANDA207616 |
| Rosuvastatin | ROSUVASTATIN | AvPAK | 7cd6ae8d-aa67-60db-e053-2991aa0a0ede | 2025-07-15 | Warnings, Adverse reactions | 207616 ANDA207616 50268-709 50268-710 50268-711 |
| Rosuvastatin | ROSUVASTATIN | Proficient Rx LP | f42139aa-bb38-4791-b41e-cd8f2c922529 | 2025-01-01 | Warnings, Adverse reactions | 207616 ANDA207616 71205-044 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-882 | Rosuvastatin | Rosuvastatin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-882 | Rosuvastatin | Rosuvastatin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-883 | Rosuvastatin | Rosuvastatin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-883 | Rosuvastatin | Rosuvastatin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-884 | Rosuvastatin | Rosuvastatin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-884 | Rosuvastatin | Rosuvastatin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-885 | Rosuvastatin | Rosuvastatin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-885 | Rosuvastatin | Rosuvastatin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 50090-2722 | Rosuvastatin | Rosuvastatin | A-S Medication Solutions | ANDA | Current |
| 50090-2723 | Rosuvastatin | Rosuvastatin | A-S Medication Solutions | ANDA | Current |
| 50090-2724 | Rosuvastatin | Rosuvastatin | A-S Medication Solutions | ANDA | Current |
| 50090-2724 | Rosuvastatin | Rosuvastatin | A-S Medication Solutions | ANDA | Current |
| 50090-2724 | Rosuvastatin | Rosuvastatin | A-S Medication Solutions | ANDA | Current |
| 50090-2725 | Rosuvastatin | Rosuvastatin | A-S Medication Solutions | ANDA | Current |
| 50090-2725 | Rosuvastatin | Rosuvastatin | A-S Medication Solutions | ANDA | Current |
| 50090-2725 | Rosuvastatin | Rosuvastatin | A-S Medication Solutions | ANDA | Current |
| 50090-2725 | Rosuvastatin | Rosuvastatin | A-S Medication Solutions | ANDA | Current |
| 50090-2725 | Rosuvastatin | Rosuvastatin | A-S Medication Solutions | ANDA | Current |
| 50090-4909 | Rosuvastatin | Rosuvastatin | A-S Medication Solutions | ANDA | Current |
| 50268-709 | Rosuvastatin | Rosuvastatin | AvPAK | ANDA | Current |
| 50268-709 | Rosuvastatin | Rosuvastatin | AvPAK | ANDA | Current |
| 50268-710 | Rosuvastatin | Rosuvastatin | AvPAK | ANDA | Current |
| 50268-710 | Rosuvastatin | Rosuvastatin | AvPAK | ANDA | Current |
| 50268-711 | Rosuvastatin | Rosuvastatin | AvPAK | ANDA | Current |
| 50268-711 | Rosuvastatin | Rosuvastatin | AvPAK | ANDA | Current |
| 55700-574 | Rosuvastatin | Rosuvastatin | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-574 | Rosuvastatin | Rosuvastatin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-574 | Rosuvastatin | Rosuvastatin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-575 | Rosuvastatin | Rosuvastatin | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-575 | Rosuvastatin | Rosuvastatin | Quality Care Products, LLC | ANDA | Current |
| 55700-575 | Rosuvastatin | Rosuvastatin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-575 | Rosuvastatin | Rosuvastatin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-575 | Rosuvastatin | Rosuvastatin | Quality Care Products, LLC | ANDA | Current |
| 61919-701 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | DIRECT RX | ANDA | Current |
| 61919-701 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | Direct_Rx | ANDA | Current |
| 61919-701 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | Direct_Rx | ANDA | Current |
| 68071-2326 | Rosuvastatin | Rosuvastatin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2848 | Rosuvastatin | Rosuvastatin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7673 | Rosuvastatin | Rosuvastatin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7673 | Rosuvastatin | Rosuvastatin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7673 | Rosuvastatin | Rosuvastatin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0986 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0986 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0986 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0986 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0986 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1219 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1219 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1219 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1219 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1219 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1384 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1384 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1384 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1384 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1601 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1601 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1601 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1601 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70934-440 | Rosuvastatin | Rosuvastatin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-044 | Rosuvastatin | Rosuvastatin | Proficient Rx LP | ANDA | Current |
| 71205-044 | Rosuvastatin | Rosuvastatin | Proficient Rx LP | ANDA | Current |
| 71335-1446 | Rosuvastatin | Rosuvastatin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1446 | Rosuvastatin | Rosuvastatin | Bryant Ranch Prepack | ANDA | Current |