Application 201890
- Type
- ANDA
- Sponsor
- ANI PHARMS INC
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 |
|---|---|---|---|---|---|---|---|
| A201890-001 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-04-26 | ||
| A201890-002 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-04-26 | ||
| A201890-003 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-04-26 | ||
| A201890-004 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-04-26 |
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 | A201890-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-04-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201890-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-04-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201890-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-04-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201890-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-04-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201890-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-04-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201890-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-04-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201890-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-04-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201890-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-04-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201890-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-04-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201890-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-04-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201890-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-04-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201890-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-04-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201890-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-04-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201890-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-04-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201890-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-04-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201890-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-04-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201890-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-04-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201890-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-04-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201890-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-04-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201890-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-04-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201890-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-04-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201890-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-04-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201890-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-04-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201890-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-04-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201890-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-04-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201890-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-04-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201890-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-04-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201890-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-04-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201890-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-04-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201890-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-04-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201890-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-04-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201890-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-04-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201890-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-04-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201890-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-04-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201890-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-04-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201890-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-04-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201890-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-04-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201890-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-04-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201890-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-04-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201890-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-04-26 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A201890-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A201890-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A201890-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A201890-004 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201890-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201890-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201890-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201890-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A201890-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A201890-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A201890-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A201890-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A201890-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A201890-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A201890-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A201890-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A201890-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A201890-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A201890-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A201890-004 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A201890-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A201890-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A201890-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A201890-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A201890-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A201890-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A201890-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A201890-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A201890-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A201890-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A201890-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A201890-004 | AB | 1 | ea99ee380514… |
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 | 2026-08-24 | 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 | Amneal Pharmaceuticals NY LLC | 5ea3ca31-cfee-4978-8b7a-755986f6b091 | 2025-01-30 | 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1385 | Ezetimibe and Simvastatin | EZETIMIBE and SIMVASTATIN | Impax Generics | ANDA | Current |
| 0115-1386 | Ezetimibe and Simvastatin | EZETIMIBE and SIMVASTATIN | Impax Generics | ANDA | Current |
| 0115-1387 | Ezetimibe and Simvastatin | EZETIMIBE and SIMVASTATIN | Impax Generics | ANDA | Current |
| 0115-1388 | Ezetimibe and Simvastatin | EZETIMIBE and SIMVASTATIN | Impax Generics | ANDA | Current |