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 | NCS HealthCare of KY, LLC dba Vangard Labs | 1ddc0230-24ab-4e69-9c6c-6776c354c82c | 2024-09-13 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| simvastatin | SIMVASTATIN | Bryant Ranch Prepack | b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5 | 2024-08-08 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | Bryant Ranch Prepack | 356ed6a6-e467-4791-87ff-2ae7779fc1b0 | 2024-08-08 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | Bryant Ranch Prepack | ce3ac5e8-bdef-d195-e0a0-e1a982008efe | 2024-08-08 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | Bryant Ranch Prepack | 79ca09cd-2396-4e50-b159-1f9567115067 | 2024-08-08 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Quallent Pharmaceuticals Health LLC | 2b4255a7-f9f5-4235-8dbb-b0f03acbd624 | 2024-07-23 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | NuCare Pharmaceuticals,Inc. | 54c236ce-69c2-06ef-e054-00144ff88e88 | 2024-07-15 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | NuCare Pharmaceuticals,Inc. | 54c28733-eb99-10f6-e054-00144ff88e88 | 2024-07-10 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | NuCare Pharmaceuticals,Inc. | 8ed46bb1-9f84-4418-e053-2a95a90abd4b | 2024-06-18 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | NuCare Pharmaceuticals,Inc. | 8e986df7-3020-6755-e053-2995a90aca37 | 2024-06-18 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Bryant Ranch Prepack | 4277e75a-7f3b-4f35-ae56-0bbe095586a5 | 2024-05-22 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Bryant Ranch Prepack | 440dff4b-c377-48f3-bf24-07fd986b6fee | 2024-05-22 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | NorthStar Rx LLC | 0376351b-f1a0-43e5-a0b4-533072c49f39 | 2024-04-15 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Camber Pharmaceuticals, Inc. | 751b79c6-bba8-4d29-b69c-a2ac6453fec8 | 2024-04-05 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 2e579278-c105-4cda-92ca-a3496d846c82 | 2024-02-15 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 7fc4df06-48cb-481a-b7b2-d951def683ea | 2023-12-25 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Bryant Ranch Prepack | 14bd8444-1556-4636-9e56-28da21a852fc | 2023-10-30 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Biocon Pharma Inc, | 7b325108-6940-50a7-96b4-822a5206e568 | 2023-09-26 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | A-S Medication Solutions | 34c8c080-97b5-4580-b8fb-3fd557cdb40a | 2023-05-03 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Proficient Rx LP | dad0dd7d-3049-4be4-aaeb-8a1895d55208 | 2023-05-01 | 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 |