Application 077751
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA
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 |
|---|---|---|---|---|---|---|---|
| A077751-001 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2008-04-30 | ||
| A077751-002 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2008-04-30 | |
| A077751-003 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2008-04-30 | |
| A077751-004 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2008-04-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077751-002 | AB |
| A077751-003 | AB |
| A077751-004 | 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 | A077751-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2008-04-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077751-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2008-04-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077751-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2008-04-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077751-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2008-04-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A077751-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2008-04-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077751-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2008-04-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077751-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2008-04-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077751-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2008-04-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077751-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2008-04-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077751-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2008-04-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077751-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2008-04-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077751-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2008-04-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077751-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2008-04-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077751-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2008-04-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077751-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2008-04-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077751-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2008-04-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077751-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2008-04-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077751-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2008-04-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077751-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2008-04-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077751-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2008-04-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077751-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2008-04-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077751-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2008-04-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077751-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2008-04-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077751-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2008-04-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077751-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2008-04-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077751-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2008-04-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077751-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2008-04-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077751-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2008-04-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077751-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2008-04-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077751-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2008-04-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077751-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2008-04-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077751-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2008-04-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077751-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2008-04-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077751-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2008-04-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077751-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2008-04-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077751-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2008-04-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077751-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2008-04-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077751-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2008-04-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077751-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2008-04-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077751-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2008-04-30 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077751-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077751-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077751-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077751-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077751-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077751-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077751-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077751-004 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077751-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077751-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077751-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077751-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077751-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077751-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077751-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077751-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077751-004 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077751-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077751-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077751-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077751-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077751-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077751-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077751-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077751-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077751-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077751-004 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077751-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077751-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077751-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077751-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A077751-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A077751-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077751-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A077751-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A077751-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077751-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A077751-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A077751-004 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077751-001 | AB | 1 | 3f01610625f2… |
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 | Direct_Rx | 7f814fd9-7b35-67da-e053-2a91aa0a39dc | 2024-01-10 | Warnings, Adverse reactions | 61919-801 |
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 |
|---|---|---|---|---|---|
| 33261-867 | pravastatin sodium | pravastatin sodium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-868 | pravastatin sodium | pravastatin sodium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-953 | pravastatin sodium | pravastatin sodium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 43063-443 | pravastatin sodium | pravastatin sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-443 | pravastatin sodium | pravastatin sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-443 | pravastatin sodium | pravastatin sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-443 | pravastatin sodium | pravastatin sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-444 | pravastatin sodium | pravastatin sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-444 | pravastatin sodium | pravastatin sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-444 | pravastatin sodium | pravastatin sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-1362 | pravastatin sodium | pravastatin sodium | A-S Medication Solutions | ANDA | Current |
| 50090-1434 | pravastatin sodium | pravastatin sodium | A-S Medication Solutions | ANDA | Current |
| 51655-071 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-072 | Pravastatin Sodium | Pravastatin Sodium | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53217-203 | pravastatin sodium | pravastatin sodium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53808-0685 | pravastatin sodium | pravastatin sodium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0874 | pravastatin sodium | pravastatin sodium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0875 | pravastatin sodium | pravastatin sodium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-4784 | pravastatin sodium | pravastatin sodium | Cardinal Health | ANDA | Current |
| 55154-4982 | pravastatin sodium | pravastatin sodium | Cardinal Health | ANDA | Current |
| 55154-4999 | pravastatin sodium | pravastatin sodium | Cardinal Health | ANDA | Current |
| 61919-801 | Pravastatin Sodium | Pravastatin Sodium | Direct_Rx | ANDA | Current |
| 61919-801 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Direct_Rx | ANDA | Current |
| 61919-801 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Direct_Rx | ANDA | Current |
| 63187-413 | pravastatin sodium | pravastatin sodium | Proficient Rx LP | ANDA | Current |
| 63187-413 | pravastatin sodium | pravastatin sodium | Proficient Rx LP | ANDA | Current |
| 63187-413 | pravastatin sodium | pravastatin sodium | Proficient Rx LP | ANDA | Current |
| 63187-415 | pravastatin sodium | pravastatin sodium | Proficient Rx LP | ANDA | Current |
| 63187-415 | pravastatin sodium | pravastatin sodium | Proficient Rx LP | ANDA | Current |
| 63187-415 | pravastatin sodium | pravastatin sodium | Proficient Rx LP | ANDA | Current |
| 63629-4588 | pravastatin sodium | pravastatin sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-4588 | pravastatin sodium | pravastatin sodium | Bryant Ranch Prepack | ANDA | Current |
| 63739-649 | pravastatin sodium | pravastatin sodium | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-649 | pravastatin sodium | pravastatin sodium | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-649 | pravastatin sodium | pravastatin sodium | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 65084-649 | pravastatin sodium | pravastatin sodium | McKesson Corporation dba RX Pak | ANDA | Current |
| 65084-649 | pravastatin sodium | pravastatin sodium | McKesson Corporation dba RX Pak | ANDA | Current |
| 65841-739 | pravastatin sodium | pravastatin sodium | Zydus Lifesciences Limited | ANDA | Current |
| 65841-739 | pravastatin sodium | pravastatin sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-739 | pravastatin sodium | pravastatin sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-739 | pravastatin sodium | pravastatin sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-740 | pravastatin sodium | pravastatin sodium | Zydus Lifesciences Limited | ANDA | Current |
| 65841-740 | pravastatin sodium | pravastatin sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-740 | pravastatin sodium | pravastatin sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-740 | pravastatin sodium | pravastatin sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-741 | pravastatin sodium | pravastatin sodium | Zydus Lifesciences Limited | ANDA | Current |
| 65841-741 | pravastatin sodium | pravastatin sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-741 | pravastatin sodium | pravastatin sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-741 | pravastatin sodium | pravastatin sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-742 | pravastatin sodium | pravastatin sodium | Zydus Lifesciences Limited | ANDA | Current |
| 65841-742 | pravastatin sodium | pravastatin sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-742 | pravastatin sodium | pravastatin sodium | Cadila Healthcare Limited | ANDA | Current |
| 65841-742 | pravastatin sodium | pravastatin sodium | Cadila Healthcare Limited | ANDA | Current |
| 68071-3253 | pravastatin sodium | pravastatin sodium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4707 | pravastatin sodium | pravastatin sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4707 | pravastatin sodium | pravastatin sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4707 | pravastatin sodium | pravastatin sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68382-070 | pravastatin sodium | pravastatin sodium | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-070 | pravastatin sodium | pravastatin sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-070 | pravastatin sodium | pravastatin sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-071 | pravastatin sodium | pravastatin sodium | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-071 | pravastatin sodium | pravastatin sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-071 | pravastatin sodium | pravastatin sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-072 | pravastatin sodium | pravastatin sodium | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-072 | pravastatin sodium | pravastatin sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-072 | pravastatin sodium | pravastatin sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-073 | pravastatin sodium | pravastatin sodium | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-073 | pravastatin sodium | pravastatin sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-073 | pravastatin sodium | pravastatin sodium | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70518-0707 | pravastatin sodium | pravastatin sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0707 | pravastatin sodium | pravastatin sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2002 | pravastatin sodium | pravastatin sodium | REMEDYREPACK INC. | ANDA | Current |