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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076341-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076341-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076341-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076341-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076341-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076341-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076341-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076341-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | caaa826d4ba7… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076341-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076341-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076341-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076341-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076341-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076341-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076341-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076341-004 | AB | 1 | caaa826d4ba7… |
| 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… |
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 | A-S Medication Solutions | 3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf21 | 2026-01-06 | Warnings, Adverse reactions | 076341 ANDA076341 50090-3853 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Northwind Health Company, LLC | db5b8821-dca8-9322-e053-2a95a90abdc3 | 2026-01-01 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Northwind Health Company, LLC | df75b04e-3e85-9705-e053-2995a90af83f | 2026-01-01 | Warnings, Adverse reactions | 076341 ANDA076341 51655-976 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | fd76794d-de33-4886-875c-fa05b2639f84 | 2025-12-10 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Coupler LLC | 4573c42b-6d4a-e001-e063-6294a90acea1 | 2025-12-08 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 12943de2-c7e9-4651-89f3-fc6cb5276676 | 2025-11-17 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 97123f09-b5ad-45c2-8bb7-f50566b56b08 | 2025-11-17 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 2ba7af14-9c87-4eb0-84c9-7e895cd75fae | 2025-11-14 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | abcfc343-7ac9-4fce-b368-fd05cf14b0e2 | 2025-11-04 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 03e27551-b3bf-47dd-b3ec-cd9a66ace3c4 | 2025-10-30 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Aphena Pharma Solutions - Tennessee, LLC | 2e5cfae8-20b8-1fea-e063-6394a90a4e17 | 2025-02-17 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | 7b900a28-f20e-49d5-98a9-5513fee0a901 | 2025-01-30 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | DIRECT RX | 97178675-3691-2d93-e053-2995a90aa5c1 | 2025-01-17 | Warnings, Adverse reactions | 076341 ANDA076341 |
| Pravastatin Sodium | PRAVASTATIN SODIUM | Lake Erie Medical DBA Quality Care Products LLC | e7194af1-6304-4e3e-88ab-0825706a3962 | 2024-12-11 | Warnings, Adverse reactions | 076341 ANDA076341 35356-919 35356-125 35356-921 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | A-S Medication Solutions | 7b4ef7a8-47e5-428f-91de-7307dcbb9167 | 2024-10-23 | Warnings, Adverse reactions | 076341 ANDA076341 50090-3204 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | NuCare Pharmaceuticals, Inc. | 54228087-7ab0-5561-e054-00144ff8d46c | 2024-07-10 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | NuCare Pharmaceuticals,Inc. | 548bdd9f-dcc6-28c7-e054-00144ff8d46c | 2024-07-10 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | NuCare Pharmaceuticals,Inc. | 8e9d5896-0b7c-dbd4-e053-2a95a90ae2f6 | 2024-06-18 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | NuCare Pharmaceuticals,Inc. | 8ed7879d-988c-1a27-e053-2995a90a0361 | 2024-06-18 | Warnings, Adverse reactions | 076341 ANDA076341 |
| PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Proficient Rx LP | 4d2b4607-0a46-4b58-9247-dc448ce258ec | 2023-08-01 | Warnings, Adverse reactions | 076341 ANDA076341 |
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 |
|---|---|---|---|---|---|
| 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 |