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 | 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 |
| SIMVASTATIN | SIMVASTATIN | Bryant Ranch Prepack | 7abc03f8-9d5f-4f7d-9e32-fc463ec0597c | 2026-04-15 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| Simvastatin | SIMVASTATIN | REMEDYREPACK INC. | 807e5be4-6f87-48b4-8a3b-e4ad1061e706 | 2026-04-14 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| simvastatin | SIMVASTATIN | Bryant Ranch Prepack | c03ab80c-a3ae-4634-a76b-f53740db76f5 | 2026-04-03 | Warnings, Adverse reactions | simvastatin SIMVASTATIN |
| Simvastatin | SIMVASTATIN | Golden State Medical Supply, Inc. | 4cc35f5f-2d3e-dedd-e063-6294a90a5cbe | 2026-03-26 | Warnings, Adverse reactions | Simvastatin SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | e4d8ebf3-7f9f-4725-a104-1d1bf6e6f768 | 2026-03-23 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | 0ccb324f-877d-4f32-a769-7cd1637b7fad | 2026-03-23 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | PD-Rx Pharmaceuticals, Inc. | 00896fff-081d-4553-be8c-1999a8a73dda | 2026-02-26 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | PD-Rx Pharmaceuticals, Inc. | 143bf1d6-11c5-4a1f-b106-844e0435ee13 | 2026-02-26 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | PD-Rx Pharmaceuticals, Inc. | 25d9f841-31d8-4514-ac73-ffe138ff69c7 | 2026-02-26 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Bryant Ranch Prepack | aaca7284-d2d8-42e3-b153-ddc3d2ce907c | 2026-02-10 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | Bryant Ranch Prepack | 76ea62f3-4efb-4649-829d-3f0c28d5dae7 | 2026-02-05 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | d099d003-4c7c-4e35-ad6e-94ddf20035b7 | 2026-02-03 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | A-S Medication Solutions | 3b0720d2-b240-48e4-af77-9ccda509fae7 | 2026-02-03 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| SIMVASTATIN | SIMVASTATIN | REMEDYREPACK INC. | 30fe2447-4dd3-43e6-bac5-0f754ab77c3a | 2026-01-29 | Warnings, Adverse reactions | SIMVASTATIN SIMVASTATIN |
| Simvastatin | SIMVASTATIN | XLCare Pharmaceuticals Inc. | 433f8a86-5ad3-43db-8e62-c0812dd3d723 | 2026-01-19 | 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 |