Application 077752
- Type
- ANDA
- Sponsor
- DR REDDYS LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 10MG | No | No |
| 002 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 20MG | No | No |
| 003 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 40MG | No | No |
| 004 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 80MG | No | No |
| 005 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077752-001 | SIMVASTATIN | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2006-12-20 | |
| A077752-002 | SIMVASTATIN | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2006-12-20 | |
| A077752-003 | SIMVASTATIN | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2006-12-20 | |
| A077752-004 | SIMVASTATIN | SIMVASTATIN | 80MG | TABLET / ORAL | AB | 2006-12-20 | |
| A077752-005 | SIMVASTATIN | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2008-01-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077752-001 | AB |
| A077752-002 | AB |
| A077752-003 | AB |
| A077752-004 | AB |
| A077752-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077752-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2006-12-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077752-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2006-12-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077752-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2006-12-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077752-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | 2006-12-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077752-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2008-01-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A077752-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2006-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077752-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2006-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077752-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2006-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077752-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | 2006-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077752-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2008-01-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077752-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2006-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077752-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2006-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077752-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2006-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077752-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | 2006-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077752-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2008-01-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077752-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2006-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077752-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2006-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077752-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2006-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077752-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | 2006-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077752-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2008-01-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077752-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2006-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077752-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2006-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077752-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2006-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077752-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | 2006-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077752-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2008-01-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077752-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2006-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077752-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2006-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077752-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2006-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077752-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | 2006-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077752-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2008-01-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077752-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2006-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077752-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2006-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077752-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2006-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077752-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | 2006-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077752-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2008-01-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077752-001 | SIMVASTATIN | 10MG | TABLET / ORAL | AB | 2006-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077752-002 | SIMVASTATIN | 20MG | TABLET / ORAL | AB | 2006-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077752-003 | SIMVASTATIN | 40MG | TABLET / ORAL | AB | 2006-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077752-004 | SIMVASTATIN | 80MG | TABLET / ORAL | AB | 2006-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077752-005 | SIMVASTATIN | 5MG | TABLET / ORAL | AB | 2008-01-23 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077752-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077752-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077752-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077752-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077752-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A077752-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077752-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077752-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077752-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077752-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077752-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077752-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077752-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077752-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077752-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077752-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077752-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077752-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077752-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077752-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077752-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077752-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077752-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077752-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077752-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077752-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077752-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077752-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077752-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077752-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077752-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077752-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077752-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077752-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077752-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077752-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077752-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077752-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077752-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077752-005 | AB | 1 | 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 | Lupin Pharmaceuticals, Inc. | 3e48217f-8175-4e9b-9fd0-909be4bbba95 | 2026-01-13 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| simvastatin | SIMVASTATIN | Northwind Health Company, LLC | db0f4c5a-e8e4-3ab1-e053-2995a90a1f9a | 2026-01-01 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | Northwind Health Company, LLC | f32d512f-86fa-b70f-e053-2a95a90afd01 | 2026-01-01 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Northwind Health Company, LLC | f7567996-4e81-7c12-e053-6394a90aa087 | 2026-01-01 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Northwind Health Company, LLC | f835af8f-7d84-1978-e053-6294a90a22ae | 2026-01-01 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Northwind Health Company, LLC | f68e9cf8-a63f-1d64-e053-2a95a90a4923 | 2026-01-01 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Northwind Health Company, LLC | f2f5ee7a-4f4e-12e9-e053-2a95a90a7eae | 2026-01-01 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Northwind Health Company, LLC | f86de805-e4ec-4bca-e053-6294a90a1fc3 | 2026-01-01 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Proficient Rx LP | 8e686832-1caf-425c-9ca6-7eaade43b6fe | 2026-01-01 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | QPharma, Inc. | f71f71db-e0dd-6609-e053-6294a90a4450 | 2025-12-19 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | 09fa512b-f6c1-437d-be46-a8ddd36743b4 | 2025-12-19 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | a53cfdd8-ca99-47a9-827d-1b06a0329878 | 2025-12-19 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Aphena Pharma Solutions - Tennessee, LLC | 450e722c-d55d-3e6d-e063-6394a90a5231 | 2025-12-03 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| simvastatin | SIMVASTATIN | QPharma, Inc. | c80b823c-b30f-0a9d-e053-2995a90a31e9 | 2025-12-03 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 468f87c8-75e3-444a-baeb-2d0f629802db | 2025-11-26 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 02245025-218d-4297-aeb6-91fefa178291 | 2025-11-25 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 20fa794a-c30a-485e-9e69-3818ba085a0d | 2025-11-24 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 9986b59c-aeff-4ccd-8db3-7f1c4e619420 | 2025-11-24 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 7cbf645d-b1d3-413d-a4c3-c1818ed6dfd1 | 2025-11-24 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 4312637b-1d6a-4d26-a1e8-caffcd7192df | 2025-11-24 | 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 |
|---|---|---|---|---|---|
| 0615-6579 | Simvastatin | Simvastatin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6580 | Simvastatin | Simvastatin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6581 | Simvastatin | Simvastatin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6588 | Simvastatin | Simvastatin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-5800 | Simvastatin | Simvastatin | Major Pharmaceuticals | ANDA | Current |
| 0904-5802 | Simvastatin | Simvastatin | Major Pharmaceuticals | ANDA | Current |
| 43063-080 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-080 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-080 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-080 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-080 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-162 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-162 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-162 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-162 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-162 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55111-198 | Simvastatin | Simvastatin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-199 | Simvastatin | Simvastatin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-200 | Simvastatin | Simvastatin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-268 | Simvastatin | Simvastatin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55700-223 | Simvastatin | Simvastatin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 67046-671 | Simvastatin | Simvastatin | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-674 | Simvastatin | Simvastatin | Contract Pharmacy Services-PA | ANDA | Current |
| 68645-261 | Simvastatin | Simvastatin | Legacy Pharmaceutical Packaging | ANDA | Current |
| 68645-262 | Simvastatin | Simvastatin | Legacy Pharmaceutical Packaging | ANDA | Current |
| 68645-263 | Simvastatin | Simvastatin | Legacy Pharmaceutical Packaging | ANDA | Current |
| 68788-9835 | Simvastatin | Simvastatin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9836 | Simvastatin | Simvastatin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 75921-200 | Simvastatin | Simvastatin | Life Line Home Care Services, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23886 | ORIG | 2011-05-26 |