Application 208831
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | TABLET;ORAL | 10MG;10MG | No | No |
| 002 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | TABLET;ORAL | 10MG;20MG | No | No |
| 003 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | TABLET;ORAL | 10MG;40MG | No | No |
| 004 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | TABLET;ORAL | 10MG;80MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208831-001 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-11-21 | ||
| A208831-002 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-11-21 | ||
| A208831-003 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-11-21 | ||
| A208831-004 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-11-21 |
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 | A208831-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-11-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208831-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-11-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208831-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-11-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208831-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-11-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208831-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-11-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208831-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-11-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208831-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-11-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208831-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-11-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208831-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-11-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208831-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-11-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208831-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-11-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208831-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-11-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208831-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-11-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208831-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-11-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208831-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-11-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208831-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-11-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208831-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-11-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208831-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-11-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208831-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-11-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208831-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-11-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208831-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-11-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208831-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-11-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208831-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-11-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208831-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-11-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208831-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-11-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208831-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-11-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208831-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-11-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208831-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-11-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208831-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-11-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208831-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-11-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208831-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-11-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208831-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-11-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208831-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-11-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208831-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-11-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208831-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-11-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208831-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-11-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208831-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-11-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208831-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-11-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208831-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-11-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208831-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-11-21 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208831-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208831-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208831-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208831-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208831-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208831-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208831-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208831-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208831-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208831-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208831-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208831-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208831-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208831-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208831-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208831-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208831-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208831-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208831-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208831-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208831-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208831-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208831-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208831-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208831-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208831-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208831-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208831-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208831-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208831-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208831-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208831-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208831-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208831-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208831-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208831-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208831-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208831-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208831-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208831-004 | AB | 1 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| ezetimibe and simvastatin | EZETIMIBE AND SIMVASTATIN | NORTHSTAR RX LLC | 52a46269-2262-4052-a3ff-5455523f591f | 2026-09-01 | Warnings, Adverse reactions | ezetimibe and simvastatin |
| Ezetimibe and Simvastatin | EZETIMIBE AND SIMVASTATIN | A-S Medication Solutions | 2ce219a2-1eeb-4ece-bb87-3810e593ca51 | 2026-02-06 | Warnings, Adverse reactions | Ezetimibe and Simvastatin |
| Ezetimibe and Simvastatin | EZETIMIBE AND SIMVASTATIN | Golden State Medical Supply, Inc. | 88cd0e7b-e8dc-6125-e053-2a95a90aaa27 | 2025-11-24 | Warnings, Adverse reactions | Ezetimibe and Simvastatin |
| Ezetimibe and Simvastatin | EZETIMIBE AND SIMVASTATIN | Dr.Reddys Laboratories Inc | 023ca87a-1b04-8c17-dc4f-e2758b0771e2 | 2025-07-18 | Warnings, Adverse reactions | Ezetimibe and Simvastatin |
| Ezetimibe and Simvastatin | EZETIMIBE AND SIMVASTATIN | Ascend Laboratories, LLC | c90e8c96-e130-42d7-bf0d-5833652e40d5 | 2025-05-02 | Warnings, Adverse reactions | Ezetimibe and Simvastatin |
| Ezetimibe and Simvastatin | EZETIMIBE AND SIMVASTATIN | Aurobindo Pharma Limited | 79dadfde-35c7-4937-9c82-1728fb6be2fb | 2024-10-22 | Warnings, Adverse reactions | Ezetimibe and Simvastatin |
| ezetimibe and simvastatin | EZETIMIBE AND SIMVASTATIN | Glenmark Pharmaceuticals Inc., USA | 32d0e130-1211-44ca-be60-5379ffec96fd | 2024-04-30 | Warnings, Adverse reactions | ezetimibe and simvastatin |
| ezetimibe and simvastatin | EZETIMIBE AND SIMVASTATIN | A-S Medication Solutions | 2c936363-b483-46c6-936c-a07d8ab0280c | 2024-01-16 | Warnings, Adverse reactions | ezetimibe and simvastatin |
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 |
|---|---|---|---|---|---|
| 42291-078 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | AvKARE | ANDA | Current |
| 42291-079 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | AvKARE | ANDA | Current |
| 42291-080 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | AvKARE | ANDA | Current |
| 42291-081 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | AvKARE | ANDA | Current |
| 50090-3984 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | A-S Medication Solutions | ANDA | Current |
| 60219-1155 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-1156 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-1157 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-1158 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 62559-700 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-700 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-700 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-700 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-700 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-701 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-701 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-701 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-701 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-701 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-702 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-702 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-702 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-702 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-702 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-703 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-703 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-703 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-703 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-703 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 69238-1155 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1155 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1155 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1155 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1155 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1155 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1155 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1156 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1156 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1156 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1156 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1156 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1156 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1156 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1157 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1157 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1157 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1157 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1157 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1157 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1157 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1158 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1158 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1158 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1158 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1158 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1158 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1158 | Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | Amneal Pharmaceuticals NY LLC | ANDA | Current |