Application 206434
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
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 |
|---|---|---|---|---|---|---|---|
| A206434-001 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | |
| A206434-002 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | |
| A206434-003 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | |
| A206434-004 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206434-001 | AB |
| A206434-002 | AB |
| A206434-003 | AB |
| A206434-004 | 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 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206434-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-004 | 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 | A206434-001 | 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 | A206434-002 | 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 | A206434-003 | 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 | A206434-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-10-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-004 | 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 | A206434-001 | 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 | A206434-002 | 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 | A206434-003 | 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 | A206434-004 | 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 | A206434-001 | 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 | A206434-002 | 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 | A206434-003 | 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 | A206434-004 | 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 | A206434-001 | 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 | A206434-002 | 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 | A206434-003 | 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 | A206434-004 | 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 | A206434-001 | 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 | A206434-002 | 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 | A206434-003 | 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 | A206434-004 | 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 | A206434-001 | 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 | A206434-002 | 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 | A206434-003 | 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 | A206434-004 | 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 | A206434-001 | 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 | A206434-002 | 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 | A206434-003 | 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 | A206434-004 | 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 | A206434-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206434-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206434-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206434-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206434-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206434-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206434-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206434-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206434-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206434-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206434-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206434-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206434-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206434-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206434-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206434-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206434-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206434-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206434-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206434-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206434-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206434-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206434-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206434-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206434-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206434-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206434-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206434-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206434-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206434-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206434-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206434-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206434-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206434-004 | 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 CALCIUM | ROSUVASTATIN CALCIUM | Bryant Ranch Prepack | bf40166a-4f73-47ff-938b-2bdbf7f000e4 | 2026-05-19 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin | ROSUVASTATIN | Accord Healthcare Inc. | 3ffe0294-3997-2755-e054-00144ff8d46c | 2025-11-14 | Warnings, Adverse reactions | 206434 ANDA206434 16729-286 16729-287 16729-285 16729-284 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Preferred Pharmaceuticals Inc. | 662c6f1a-ca1e-40ea-952d-122b680fdb89 | 2025-01-09 | Warnings, Adverse reactions | 206434 ANDA206434 68788-7086 |
| Rosuvastatin | ROSUVASTATIN | Bryant Ranch Prepack | 0ad5b7de-e97d-4989-91e4-edae73543896 | 2024-10-30 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin | ROSUVASTATIN | Bryant Ranch Prepack | aa7443b0-9f75-47fc-a5ce-c7245444419c | 2024-10-30 | Warnings, Adverse reactions | 206434 ANDA206434 |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | Proficient Rx LP | eaf91ddd-0d4f-4c77-9dba-a2a3abb86ea4 | 2022-11-01 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | aa64d28f-0926-4ff2-bb28-578e5ef233eb | 2022-11-01 | Warnings, Adverse reactions | 206434 ANDA206434 71205-099 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | a1b4d50b-eda3-437c-9c80-4d854361ddc2 | 2022-11-01 | Warnings, Adverse reactions | 206434 ANDA206434 71205-176 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | 5a874865-3cbe-4589-9787-046feb9a2c46 | 2022-11-01 | Warnings, Adverse reactions | 206434 ANDA206434 71205-008 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | a5ee9510-e691-49ec-a5cd-49e70371ee4d | 2019-01-09 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | 410a0a03-6751-4c3d-82bf-c7c6a4081fdd | 2018-11-13 | Warnings, Adverse reactions | 206434 ANDA206434 |
| Rosuvastatin calcium | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | 69dfa637-2a81-4c7e-8fef-d4b4ab4c3f25 | 2018-06-30 | Warnings, Adverse reactions | 206434 ANDA206434 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-284 | Rosuvastatin calcium | Rosuvastatin calcium | Accord Healthcare Inc. | ANDA | Current |
| 16729-284 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | Accord Healthcare Inc. | ANDA | Current |
| 16729-284 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-284 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-284 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-284 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-285 | Rosuvastatin calcium | Rosuvastatin calcium | Accord Healthcare Inc. | ANDA | Current |
| 16729-285 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | Accord Healthcare Inc. | ANDA | Current |
| 16729-285 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-285 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-285 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-285 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-286 | Rosuvastatin calcium | Rosuvastatin calcium | Accord Healthcare Inc. | ANDA | Current |
| 16729-286 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | Accord Healthcare Inc. | ANDA | Current |
| 16729-286 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-286 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-286 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-286 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-287 | Rosuvastatin calcium | Rosuvastatin calcium | Accord Healthcare Inc. | ANDA | Current |
| 16729-287 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | Accord Healthcare Inc. | ANDA | Current |
| 16729-287 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-287 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-287 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 16729-287 | Rosuvastatin | Rosuvastatin | Accord Healthcare Inc. | ANDA | Current |
| 45865-894 | Rosuvastatin calcium | Rosuvastatin calcium | medsource pharmaceuticals | ANDA | Current |
| 50090-3176 | Rosuvastatin calcium | Rosuvastatin calcium | A-S Medication Solutions | ANDA | Current |
| 50090-3177 | Rosuvastatin calcium | Rosuvastatin | A-S Medication Solutions | ANDA | Current |
| 50090-3177 | Rosuvastatin calcium | Rosuvastatin calcium | A-S Medication Solutions | ANDA | Current |
| 50090-3177 | Rosuvastatin calcium | Rosuvastatin calcium | A-S Medication Solutions | ANDA | Current |
| 50090-3177 | Rosuvastatin calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | ANDA | Current |
| 50090-3437 | Rosuvastatin calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | ANDA | Current |
| 50090-3437 | Rosuvastatin calcium | Rosuvastatin calcium | A-S Medication Solutions | ANDA | Current |
| 50090-3706 | Rosuvastatin calcium | Rosuvastatin calcium | A-S Medication Solutions | ANDA | Current |
| 50090-3706 | Rosuvastatin calcium | Rosuvastatin calcium | A-S Medication Solutions | ANDA | Current |
| 53217-348 | Rosuvastatin calcium | Rosuvastatin calcium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55700-978 | Rosuvastatin | Rosuvastatin | Quality Care Products, LLC | ANDA | Current |
| 61919-712 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | DIRECT RX | ANDA | Current |
| 61919-712 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | DIRECT RX | ANDA | Current |
| 63629-8124 | Rosuvastatin calcium | Rosuvastatin calcium | Bryant Ranch Prepack | ANDA | Current |
| 63629-8124 | Rosuvastatin calcium | Rosuvastatin calcium | Bryant Ranch Prepack | ANDA | Current |
| 68071-2816 | Rosuvastatin | Rosuvastatin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2885 | Rosuvastatin | Rosuvastatin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4765 | Rosuvastatin calcium | Rosuvastatin calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4765 | Rosuvastatin calcium | Rosuvastatin calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6955 | Rosuvastatin calcium | Rosuvastatin calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6955 | Rosuvastatin calcium | Rosuvastatin calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7086 | Rosuvastatin calcium | Rosuvastatin calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7086 | Rosuvastatin calcium | Rosuvastatin calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7086 | Rosuvastatin calcium | Rosuvastatin calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7971 | Rosuvastatin | Rosuvastatin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7971 | Rosuvastatin | Rosuvastatin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0375 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0375 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0375 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0375 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0404 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0484 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0484 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0484 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1169 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1169 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1311 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1311 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1311 | Rosuvastatin calcium | Rosuvastatin calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-3519 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3519 | Rosuvastatin | Rosuvastatin | REMEDYREPACK INC. | ANDA | Current |
| 70934-275 | Rosuvastatin calcium | Rosuvastatin calcium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-275 | Rosuvastatin calcium | Rosuvastatin calcium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-275 | Rosuvastatin Calcium | Rosuvastatin Calcium | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71205-008 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |
| 71205-008 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |
| 71205-008 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |
| 71205-008 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |
| 71205-099 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |
| 71205-099 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |
| 71205-099 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |
| 71205-099 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |
| 71205-176 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |
| 71205-176 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |
| 71205-176 | Rosuvastatin calcium | Rosuvastatin calcium | Proficient Rx LP | ANDA | Current |