Application 076341
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 10MG | No | No |
| 002 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 20MG | No | No |
| 003 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 40MG | No | No |
| 004 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 80MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076341-001 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | |
| A076341-002 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | |
| A076341-003 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | |
| A076341-004 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076341-001 | AB |
| A076341-002 | AB |
| A076341-003 | AB |
| A076341-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076341-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076341-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076341-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076341-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076341-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076341-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076341-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076341-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076341-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076341-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076341-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076341-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076341-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076341-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076341-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076341-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076341-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076341-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076341-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076341-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076341-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076341-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076341-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076341-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076341-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076341-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076341-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076341-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076341-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076341-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076341-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076341-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076341-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076341-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076341-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076341-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076341-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076341-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076341-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076341-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076341-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076341-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076341-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076341-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076341-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076341-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076341-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076341-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076341-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076341-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076341-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076341-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076341-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076341-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076341-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076341-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076341-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076341-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076341-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076341-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076341-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076341-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076341-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076341-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076341-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076341-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076341-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076341-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076341-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076341-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076341-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076341-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076341-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076341-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076341-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076341-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076341-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076341-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076341-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076341-004 | AB | 1 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Quallent | e9c188f7-cd6f-afac-b493-36552d86589e | 2026-08-03 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Apotex Corp. | dcf45e4f-b46e-6fbb-b67a-2ff619ab1780 | 2026-07-31 | Warnings, Adverse reactions | 076341 ANDA076341 60505-0168 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | REMEDYREPACK INC. | e4dbaa72-7b3e-4aef-983b-90efb2b343cd | 2026-07-16 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | PD-Rx Pharmaceuticals, Inc. | c5f611aa-9974-422e-a353-5d834a33937c | 2026-07-07 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | PD-Rx Pharmaceuticals, Inc. | 8dbdc80d-9d8c-4e22-9108-d87a77e07a6b | 2026-07-07 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | REMEDYREPACK INC. | 5ecd9fd1-7662-412d-99c5-13c77188748c | 2026-07-01 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | REMEDYREPACK INC. | 76e5fdf8-bd03-4cd5-9361-e61678cb3de9 | 2026-06-26 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Cardinal Health 107, LLC | 3e218ad6-5b47-4cca-81be-ebaea5795964 | 2026-06-26 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Cardinal Health 107, LLC | 9289f9ed-b6e3-4e81-bdb8-6aedbd5288a9 | 2026-06-11 | Warnings, Adverse reactions | 076341 ANDA076341 55154-7275 55154-7998 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 14390bfa-3bcb-43e1-936c-1977cb37427d | 2026-06-04 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 8d1bf7a5-bf11-47e3-afca-dcc13f2d3068 | 2026-06-04 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Northwind Health Company, LLC | 4fad5d73-aa79-58f2-e063-6294a90af4aa | 2026-04-16 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | 93b0e546-9e0f-40d1-9b1e-082bf16400a4 | 2026-04-13 | Warnings, Adverse reactions | 076341 ANDA076341 50090-2024 50090-2025 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | d69e8af8-dbd4-43d9-8e9a-4aed3923a17c | 2026-04-13 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | f4b330ce-dfb0-4e4e-9f37-482458820c66 | 2026-03-25 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Major Pharmaceuticals | 1d5bce9c-a788-4c52-a69e-c53174b8d061 | 2026-03-02 | Warnings, Adverse reactions | 076341 ANDA076341 0904-5893 0904-5891 0904-5892 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | NCS HealthCare of KY, LLC dba Vangard Labs | 64ccb4b5-b77e-4b23-8c74-4685287edb4b | 2026-02-27 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | c0b1b483-1a19-4966-89b1-118ec660f203 | 2026-01-29 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ba4ac602-46fa-8386-e053-2995a90a9764 | 2026-01-09 | Warnings, Adverse reactions | 076341 ANDA076341 50268-666 50268-668 50268-667 50268-665 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | 3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf21 | 2026-01-06 | Warnings, Adverse reactions | 076341 ANDA076341 50090-3853 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-5891 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Major Pharmaceuticals | ANDA | Current |
| 0904-5891 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Major Pharmaceuticals | ANDA | Current |
| 0904-5891 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Major Pharmaceuticals | ANDA | Current |
| 0904-5892 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Major Pharmaceuticals | ANDA | Current |
| 0904-5892 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Major Pharmaceuticals | ANDA | Current |
| 0904-5892 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Major Pharmaceuticals | ANDA | Current |
| 0904-5893 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Major Pharmaceuticals | ANDA | Current |
| 0904-5893 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Major Pharmaceuticals | ANDA | Current |
| 0904-5893 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Major Pharmaceuticals | ANDA | Current |
| 35356-125 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-125 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-125 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-125 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-125 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-125 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-919 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-919 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-919 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-919 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-919 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-919 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-921 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-921 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-921 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-921 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-921 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-921 | Pravastatin Sodium | pravastatin sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 43353-474 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 50090-2024 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | ANDA | Current |
| 50090-2024 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | ANDA | Current |
| 50090-2025 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | ANDA | Current |
| 50090-2025 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | ANDA | Current |
| 50090-2025 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | ANDA | Current |
| 50090-3204 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | ANDA | Current |
| 50090-3204 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | ANDA | Current |
| 50090-3204 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | ANDA | Current |
| 50090-3853 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | ANDA | Current |
| 50090-3853 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | ANDA | Current |
| 50090-3853 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | ANDA | Current |
| 50268-665 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-665 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-665 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-665 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-666 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-666 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-666 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-666 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-667 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-667 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-667 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-667 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-668 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-668 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-668 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50268-668 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | AvPAK | ANDA | Current |
| 50436-3800 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Unit Dose Services | ANDA | Current |
| 50436-6617 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Unit Dose Services | ANDA | Current |
| 51655-976 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Northwind Pharmaceuticals | ANDA | Current |
| 53217-379 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53808-0536 | Pravastatin Sodium | Pravastatin Sodium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0538 | Pravastatin Sodium | Pravastatin Sodium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-7275 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Cardinal Health | ANDA | Current |
| 55154-7275 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Cardinal Health | ANDA | Current |
| 55154-7275 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7275 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Cardinal Health | ANDA | Current |
| 55154-7275 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Cardinal Health | ANDA | Current |
| 55154-7998 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Cardinal Health | ANDA | Current |
| 55154-7998 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Cardinal Health | ANDA | Current |
| 55154-7998 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7998 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Cardinal Health | ANDA | Current |
| 55154-7998 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Cardinal Health | ANDA | Current |
| 60429-367 | Pravastatin Sodium | pravastatin sodium | Golden State Medical Supply | ANDA | Current |
| 60429-367 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Golden State Medical Supply | ANDA | Current |
| 60429-368 | Pravastatin Sodium | pravastatin sodium | Golden State Medical Supply | ANDA | Current |
| 60429-368 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Golden State Medical Supply | ANDA | Current |
| 60429-369 | Pravastatin Sodium | pravastatin sodium | Golden State Medical Supply | ANDA | Current |
| 60429-369 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Golden State Medical Supply | ANDA | Current |
| 60505-0168 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Apotex Corp. | ANDA | Current |
| 60505-0168 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Apotex Corp. | ANDA | Current |
| 60505-0168 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Apotex Corp. | ANDA | Current |