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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076052-001 | SIMVASTATIN | 5MG | TABLET / ORAL | 2006-06-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076052-002 | SIMVASTATIN | 10MG | TABLET / ORAL | 2006-06-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076052-003 | SIMVASTATIN | 20MG | TABLET / ORAL | 2006-06-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076052-004 | SIMVASTATIN | 40MG | TABLET / ORAL | 2006-06-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076052-005 | SIMVASTATIN | 80MG | TABLET / ORAL | 2006-12-20 | 84e616aacf4f… | ||
| 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… |
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 | A-S Medication Solutions | a2b879ae-eaf3-4a36-abd0-986add4a73ac | 2025-11-24 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 66777aaa-370a-4121-9246-c0866098f4a4 | 2025-11-24 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 658cf877-f7cd-4ec8-84a3-08c27a06ccda | 2025-11-24 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | Accord Healthcare, Inc. | 871251c0-36a1-4a32-9eab-ff6c1e925ca9 | 2025-11-14 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | American Health Packaging | 4bec3923-6221-4b8b-9a72-872a63680de1 | 2025-08-25 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | American Health Packaging | 51dd8d34-e660-49dc-a86e-07d031a18465 | 2025-05-20 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 6de29f85-92e9-4a28-9bcc-6789f2f698de | 2025-04-25 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 9133520e-1ffd-4ef1-bced-6b0c9a579f39 | 2025-04-24 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Westminster Pharmaceuticals, LLC | acaaab63-c9ff-44c9-8fde-9a4ea6454dd7 | 2025-04-21 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| ZOCOR | SIMVASTATIN | Organon LLC | 8f55d5de-5a4f-4a39-8c84-c53976dd6af9 | 2025-03-28 | Warnings, Adverse reactions | SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 492f6b4e-ca25-4f59-9f9d-3f465061b7b1 | 2025-02-12 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | NuCare Pharmaceuticals,Inc. | cf85b795-82fa-3389-e053-2995a90af2fd | 2025-02-10 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | NuCare Pharmaceuticals,Inc. | cf859977-2d84-0fcb-e053-2a95a90a6269 | 2025-02-10 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | NuCare Pharmaceuticals,Inc. | 06703194-b41a-2bbe-e063-6394a90ac41f | 2025-02-04 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| Simvastatin | SIMVASTATIN | NuCare Pharmaceuticals,Inc. | 0a1fe17b-75d4-d361-e063-6394a90ae188 | 2025-02-03 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | NuCare Pharmaceuticals,Inc. | 673dfc44-d407-f9ac-e053-2a91aa0a4702 | 2025-02-03 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Direct_Rx | f42246de-62d2-212f-e053-2a95a90ac88a | 2025-01-22 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Direct_Rx | f5dd1835-6d40-40da-e053-2a95a90ad121 | 2025-01-22 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Direct_Rx | f7aa095f-590c-98e3-e053-6394a90ad972 | 2025-01-22 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | NuCare Pharmaceuticals,Inc. | 56456210-2db5-4f0d-e054-00144ff8d46c | 2024-12-26 | Warnings, Adverse reactions | simvastatin 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 |
|---|---|---|---|---|---|
| 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 |