Application 208898
- Type
- ANDA
- Sponsor
- MSN
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 |
|---|---|---|---|---|---|---|---|
| A208898-001 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-11-22 | |
| A208898-002 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-11-22 | |
| A208898-003 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-11-22 | |
| A208898-004 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-11-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208898-001 | AB |
| A208898-002 | AB |
| A208898-003 | AB |
| A208898-004 | 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 | A208898-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-11-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A208898-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-11-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A208898-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-11-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A208898-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-11-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A208898-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-11-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208898-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-11-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208898-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-11-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208898-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-11-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208898-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-11-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208898-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-11-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208898-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-11-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208898-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-11-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208898-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-11-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208898-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-11-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208898-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-11-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208898-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-11-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208898-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-11-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208898-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-11-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208898-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-11-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208898-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-11-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208898-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-11-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208898-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-11-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208898-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-11-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208898-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-11-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208898-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-11-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208898-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-11-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208898-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-11-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208898-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-11-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208898-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-11-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208898-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-11-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208898-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-11-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208898-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-11-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208898-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-11-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208898-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-11-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208898-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-11-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208898-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-11-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208898-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-11-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208898-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-11-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208898-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-11-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208898-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-11-22 | 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 | A208898-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A208898-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A208898-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A208898-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A208898-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208898-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208898-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208898-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A208898-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208898-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208898-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208898-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208898-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208898-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208898-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208898-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208898-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208898-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208898-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208898-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208898-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208898-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208898-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208898-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208898-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208898-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208898-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208898-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208898-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208898-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208898-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208898-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208898-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208898-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208898-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208898-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208898-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208898-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208898-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208898-004 | 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 |
|---|---|---|---|---|---|---|
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | 2e998dc7-e2a5-41e4-8758-aff545bb1f14 | 2023-09-06 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | 3a138e43-f123-47d1-b241-d3bcc7584e51 | 2023-09-06 | Warnings, Adverse reactions | 208898 ANDA208898 50090-5770 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | 8046d4fa-bd89-49f7-8204-9eb49b648748 | 2023-08-31 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | ee4f7a00-b330-47ed-8440-7317b43753cf | 2023-08-31 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | e24da1b9-e51d-489a-85f4-43227c210477 | 2023-06-15 | Warnings, Adverse reactions | 208898 ANDA208898 |
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 |
|---|---|---|---|---|---|
| 50090-5110 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-5770 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 61919-786 | Rosuvastatin | Rosuvastatin | Direct_Rx | ANDA | Current |
| 61919-786 | Rosuvastatin | Rosuvastatin | Direct_Rx | ANDA | Current |
| 61919-799 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUN | DIRECT RX | ANDA | Current |
| 61919-799 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUN | DIRECT RX | ANDA | Current |
| 68071-2378 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2379 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4764 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4764 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4896 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4896 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4896 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4896 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5176 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5176 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5176 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5225 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5225 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7310 | Rosuvastatin Calcium | Rosuvastatin Calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7310 | Rosuvastatin Calcium | Rosuvastatin Calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7310 | Rosuvastatin Calcium | Rosuvastatin Calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7566 | Rosuvastatin Calcium | Rosuvastatin Calcium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7566 | Rosuvastatin Calcium | Rosuvastatin Calcium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7612 | Rosuvastatin Calcium | Rosuvastatin Calcium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7612 | Rosuvastatin Calcium | Rosuvastatin Calcium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7612 | Rosuvastatin Calcium | Rosuvastatin Calcium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69539-007 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-007 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-007 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-008 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-008 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-008 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-009 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-009 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-009 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-010 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-010 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-010 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-160 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-160 | Rosuvastatin Calcium | Rosuvastatin Calcium | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 70518-1726 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1726 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1819 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1819 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1819 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1819 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1819 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1819 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2055 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2055 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2055 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2055 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2055 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2090 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2090 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2090 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2542 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2542 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2542 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2774 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2774 | Rosuvastatin Calcium | Rosuvastatin Calcium | REMEDYREPACK INC. | ANDA | Current |
| 70934-244 | Rosuvastatin Calcium | Rosuvastatin Calcium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-244 | Rosuvastatin Calcium | Rosuvastatin Calcium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-245 | Rosuvastatin Calcium | Rosuvastatin Calcium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-245 | Rosuvastatin Calcium | Rosuvastatin Calcium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-399 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 71335-1017 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1017 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1017 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1017 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1017 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1098 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1098 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1098 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1103 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1103 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1103 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1330 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1330 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |