Application 076052
- Type
- ANDA
- Sponsor
- IVAX SUB TEVA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 5MG | No | No |
| 002 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 10MG | No | No |
| 003 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 20MG | No | No |
| 004 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 40MG | No | No |
| 005 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 80MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076052-001 | SIMVASTATIN | SIMVASTATIN | 5MG | TABLET / ORAL | 2006-06-23 | ||
| A076052-002 | SIMVASTATIN | SIMVASTATIN | 10MG | TABLET / ORAL | 2006-06-23 | ||
| A076052-003 | SIMVASTATIN | SIMVASTATIN | 20MG | TABLET / ORAL | 2006-06-23 | ||
| A076052-004 | SIMVASTATIN | SIMVASTATIN | 40MG | TABLET / ORAL | 2006-06-23 | ||
| A076052-005 | SIMVASTATIN | SIMVASTATIN | 80MG | TABLET / ORAL | 2006-12-20 |
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 | A076052-001 | SIMVASTATIN | 5MG | TABLET / ORAL | 2006-06-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076052-002 | SIMVASTATIN | 10MG | TABLET / ORAL | 2006-06-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076052-003 | SIMVASTATIN | 20MG | TABLET / ORAL | 2006-06-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076052-004 | SIMVASTATIN | 40MG | TABLET / ORAL | 2006-06-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076052-005 | SIMVASTATIN | 80MG | TABLET / ORAL | 2006-12-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076052-001 | SIMVASTATIN | 5MG | TABLET / ORAL | 2006-06-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076052-002 | SIMVASTATIN | 10MG | TABLET / ORAL | 2006-06-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076052-003 | SIMVASTATIN | 20MG | TABLET / ORAL | 2006-06-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076052-004 | SIMVASTATIN | 40MG | TABLET / ORAL | 2006-06-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076052-005 | SIMVASTATIN | 80MG | TABLET / ORAL | 2006-12-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076052-001 | SIMVASTATIN | 5MG | TABLET / ORAL | 2006-06-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076052-002 | SIMVASTATIN | 10MG | TABLET / ORAL | 2006-06-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076052-003 | SIMVASTATIN | 20MG | TABLET / ORAL | 2006-06-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076052-004 | SIMVASTATIN | 40MG | TABLET / ORAL | 2006-06-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076052-005 | SIMVASTATIN | 80MG | TABLET / ORAL | 2006-12-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076052-001 | SIMVASTATIN | 5MG | TABLET / ORAL | 2006-06-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076052-002 | SIMVASTATIN | 10MG | TABLET / ORAL | 2006-06-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076052-003 | SIMVASTATIN | 20MG | TABLET / ORAL | 2006-06-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076052-004 | SIMVASTATIN | 40MG | TABLET / ORAL | 2006-06-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076052-005 | SIMVASTATIN | 80MG | TABLET / ORAL | 2006-12-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076052-001 | SIMVASTATIN | 5MG | TABLET / ORAL | 2006-06-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076052-002 | SIMVASTATIN | 10MG | TABLET / ORAL | 2006-06-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076052-003 | SIMVASTATIN | 20MG | TABLET / ORAL | 2006-06-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076052-004 | SIMVASTATIN | 40MG | TABLET / ORAL | 2006-06-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076052-005 | SIMVASTATIN | 80MG | TABLET / ORAL | 2006-12-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076052-001 | SIMVASTATIN | 5MG | TABLET / ORAL | 2006-06-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076052-002 | SIMVASTATIN | 10MG | TABLET / ORAL | 2006-06-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076052-003 | SIMVASTATIN | 20MG | TABLET / ORAL | 2006-06-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076052-004 | SIMVASTATIN | 40MG | TABLET / ORAL | 2006-06-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076052-005 | SIMVASTATIN | 80MG | TABLET / ORAL | 2006-12-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076052-001 | SIMVASTATIN | 5MG | TABLET / ORAL | 2006-06-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076052-002 | SIMVASTATIN | 10MG | TABLET / ORAL | 2006-06-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076052-003 | SIMVASTATIN | 20MG | TABLET / ORAL | 2006-06-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076052-004 | SIMVASTATIN | 40MG | TABLET / ORAL | 2006-06-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076052-005 | SIMVASTATIN | 80MG | TABLET / ORAL | 2006-12-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076052-001 | SIMVASTATIN | 5MG | TABLET / ORAL | 2006-06-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076052-002 | SIMVASTATIN | 10MG | TABLET / ORAL | 2006-06-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076052-003 | SIMVASTATIN | 20MG | TABLET / ORAL | 2006-06-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076052-004 | SIMVASTATIN | 40MG | TABLET / ORAL | 2006-06-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076052-005 | SIMVASTATIN | 80MG | TABLET / ORAL | 2006-12-20 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| Simvastatin | SIMVASTATIN | REMEDYREPACK INC. | d053fee4-b797-4a82-8865-0b4d08b14990 | 2026-08-19 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Aphena Pharma Solutions - Tennessee, LLC | 58cd6c9a-3429-24eb-e063-6394a90a6984 | 2026-08-11 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | REMEDYREPACK INC. | e59bf31f-d880-4d9e-b6c2-5a18a53718f9 | 2026-08-06 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | e447cc46-adee-4126-8b85-f00f81a6e93c | 2026-07-08 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Aphena Pharma Solutions - Tennessee, LLC | 55f92c72-e690-85dd-e063-6394a90adb39 | 2026-07-06 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | St. Mary's Medical Park Pharmacy | f94d5907-737e-df67-e053-6394a90a82a6 | 2026-07-01 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Bryant Ranch Prepack | a3bfe314-1fe4-4d2a-aecb-4194f3bd8f22 | 2026-06-29 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | St. Mary's Medical Park Pharmacy | faa81817-3ffa-b83c-e053-6294a90a3f85 | 2026-06-02 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | St. Mary's Medical Park Pharmacy | f94e5e28-f0b1-700a-e053-6394a90adb7b | 2026-06-01 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Coupler LLC | 5257271e-5c07-4996-e063-6394a90a4424 | 2026-05-21 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Coupler LLC | 52573b98-6e51-9753-e063-6294a90ac8c4 | 2026-05-21 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | REMEDYREPACK INC. | 5ae78a86-ccca-4714-b77e-7bc885b674b5 | 2026-05-20 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Aphena Pharma Solutions - Tennessee, LLC | 522d0f7f-f20b-bc17-e063-6294a90a3648 | 2026-05-19 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | PD-Rx Pharmaceuticals, Inc. | aa8aed58-691b-472e-8e98-53d0d3f56686 | 2026-05-12 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | PD-Rx Pharmaceuticals, Inc. | 7463b093-c2ee-49c3-a08a-e758de66422a | 2026-05-12 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | PD-Rx Pharmaceuticals, Inc. | c6b610ab-7367-4e61-9b4a-7ebbd1cf3d36 | 2026-05-12 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | QPharma, Inc | f71fc0ac-223e-18c1-e053-6394a90a45ca | 2026-05-11 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Aurobindo Pharma Limited | 4724dbb4-3613-4e6a-948f-a43d34f97f06 | 2026-05-11 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Coupler LLC | 50733b85-067d-99c3-e063-6394a90a4244 | 2026-04-27 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Bryant Ranch Prepack | 5c760852-800b-463e-8059-06a9a82c2225 | 2026-04-15 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-7152 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7152 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, | ANDA | Current |
| 0093-7153 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, | ANDA | Current |
| 0093-7153 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7153 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7154 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, | ANDA | Current |
| 0093-7154 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7154 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7155 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, | ANDA | Current |
| 0093-7155 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7155 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7156 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, | ANDA | Current |
| 0093-7156 | Simvastatin | Simvastatin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0179-0128 | Simvastatin | Simvastatin | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-1897 | Simvastatin | Simvastatin | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-1898 | Simvastatin | Simvastatin | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-1899 | Simvastatin | Simvastatin | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 42708-051 | Simvastatin | Simvastatin | QPharma Inc | ANDA | Current |
| 42708-051 | Simvastatin | Simvastatin | QPharma Inc | ANDA | Current |
| 42708-052 | Simvastatin | Simvastatin | QPharma Inc | ANDA | Current |
| 42708-052 | Simvastatin | Simvastatin | QPharma Inc | ANDA | Current |
| 51079-454 | Simvastatin | Simvastatin | Mylan Institutional Inc. | ANDA | Current |
| 51079-454 | Simvastatin | Simvastatin | Mylan Institutional Inc. | ANDA | Current |
| 51079-455 | Simvastatin | Simvastatin | Mylan Institutional Inc. | ANDA | Current |
| 51079-455 | Simvastatin | Simvastatin | Mylan Institutional Inc. | ANDA | Current |
| 51079-456 | Simvastatin | Simvastatin | Mylan Institutional Inc. | ANDA | Current |
| 51079-456 | Simvastatin | Simvastatin | Mylan Institutional Inc. | ANDA | Current |
| 53808-0792 | Simvastatin | Simvastatin | State of Florida DOH Central Pharmacy | ANDA | Current |
| 54458-932 | Simvastatin | Simvastatin | International Laboratories, LLC | ANDA | Current |
| 54458-932 | Simvastatin | Simvastatin | International Laboratories, LLC | ANDA | Current |
| 54458-933 | Simvastatin | Simvastatin | International Laboratories, LLC | ANDA | Current |
| 54458-933 | Simvastatin | Simvastatin | International Laboratories, LLC | ANDA | Current |
| 54458-934 | Simvastatin | Simvastatin | International Laboratories, LLC | ANDA | Current |
| 54458-934 | Simvastatin | Simvastatin | International Laboratories, LLC | ANDA | Current |
| 55289-293 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 55289-293 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-338 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 55289-338 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 66116-316 | Simvastatin | Simvastatin | MedVantx, Inc. | ANDA | Current |
| 68071-3157 | Simvastatin | Simvastatin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68151-0177 | Simvastatin | Simvastatin | Carilion Materials Management | ANDA | Current |
| 68788-7437 | Simvastatin | Simvastatin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 71205-070 | Simvastatin | Simvastatin | Proficient Rx LP | ANDA | Current |
| 71205-070 | Simvastatin | Simvastatin | Proficient Rx LP | ANDA | Current |
| 71335-1020 | Simvastatin | Simvastatin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1020 | Simvastatin | Simvastatin | Bryant Ranch Prepack | ANDA | Current |