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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208898-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2017-11-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208898-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2017-11-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208898-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2017-11-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208898-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2017-11-22 | 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 | 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… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208898-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208898-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208898-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208898-004 | 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 | REMEDYREPACK INC. | 11fad602-16c2-4c1f-bdf1-867d95f063ca | 2026-07-14 | Warnings, Adverse reactions | 208898 ANDA208898 70518-1819 |
| ROSUVASTATIN | ROSUVASTATIN | DIRECT RX | 99602058-4681-7cb5-e053-2995a90a099c | 2026-03-05 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | be73cea2-f89a-e4c5-e053-2a95a90a9cce | 2026-03-02 | Warnings, Adverse reactions | 208898 ANDA208898 68071-2379 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Northwind Health Company, LLC | f2a1008e-963c-9999-e053-2a95a90ae726 | 2026-01-01 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Northwind Health Company, LLC | e3d92523-2dbe-930b-e053-2a95a90ac3f2 | 2026-01-01 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Preferred Pharmaceuticals Inc. | b94b5b36-c04e-45ee-b933-59c4302f2661 | 2025-09-18 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Preferred Pharmaceuticals, Inc. | 6ef51f7c-2899-4b09-bf8b-09e5b4ac3424 | 2025-09-18 | Warnings, Adverse reactions | 208898 ANDA208898 68788-7612 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Preferred Pharmaceuticals Inc. | 31b3894a-1139-4f07-ac29-dda53844dc4b | 2025-09-17 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Quallent Pharmaceuticals Health LLC | 6f978191-775e-4745-9c07-99e5be888afe | 2025-02-07 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | dc7bfc79-9ee3-46e7-b55d-aba88648ad3b | 2024-12-01 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Novadoz Pharmaceuticals LLC | d58f1f63-4bb6-413c-9730-ded3e8078618 | 2024-11-28 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Bryant Ranch Prepack | a9a5641f-9b7d-4a98-8dac-a3c53dde861f | 2024-08-29 | Warnings, Adverse reactions | 208898 ANDA208898 71335-1098 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Bryant Ranch Prepack | 199df185-dab0-4de1-95f7-a70e57b9c2b1 | 2024-08-29 | Warnings, Adverse reactions | 208898 ANDA208898 71335-1330 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | aaadbf01-9cf4-4898-9a96-f0a20d55702b | 2024-08-20 | Warnings, Adverse reactions | 208898 ANDA208898 50090-5110 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | 9e694f6a-63a0-55e9-e053-2995a90a10fe | 2024-06-20 | Warnings, Adverse reactions | 208898 ANDA208898 68071-5176 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | NuCare Pharmaceuticals,Inc. | a2155aff-bf13-3f00-e053-2995a90a4d1d | 2024-06-20 | Warnings, Adverse reactions | 208898 ANDA208898 68071-5225 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Bryant Ranch Prepack | d6645266-9626-430e-bf04-b6426525ae0a | 2024-05-17 | Warnings, Adverse reactions | 208898 ANDA208898 71335-1017 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | 3a03022c-ef11-4a68-829f-fae2d31969df | 2024-03-01 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | 7ec15f53-a7ec-4be5-9f26-d1078117b18b | 2023-12-28 | Warnings, Adverse reactions | 208898 ANDA208898 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Bryant Ranch Prepack | 8795a783-755d-426b-aa4f-1fc9965ba944 | 2023-11-20 | Warnings, Adverse reactions | 208898 ANDA208898 71335-1103 |
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 |