Application 076939
- Type
- ANDA
- Sponsor
- WATSON LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 80MG | No | No |
| 002 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 40MG | No | No |
| 003 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 20MG | No | No |
| 004 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076939-001 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | |
| A076939-002 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | |
| A076939-003 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | |
| A076939-004 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076939-001 | AB |
| A076939-002 | AB |
| A076939-003 | AB |
| A076939-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076939-001 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076939-002 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076939-003 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076939-004 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076939-001 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076939-002 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076939-003 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076939-004 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076939-001 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076939-002 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076939-003 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076939-004 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076939-001 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076939-002 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076939-003 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076939-004 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076939-001 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076939-002 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076939-003 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076939-004 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076939-001 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076939-002 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076939-003 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076939-004 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076939-001 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076939-002 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076939-003 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076939-004 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076939-001 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076939-002 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076939-003 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076939-004 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076939-001 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076939-002 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076939-003 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076939-004 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076939-001 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | AB | 2007-12-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076939-002 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | AB | 2006-10-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076939-003 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | AB | 2006-10-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076939-004 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | AB | 2006-10-23 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076939-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076939-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076939-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076939-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076939-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076939-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076939-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076939-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076939-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076939-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076939-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076939-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076939-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076939-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076939-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076939-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076939-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076939-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076939-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076939-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076939-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076939-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076939-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076939-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076939-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076939-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076939-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076939-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076939-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076939-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076939-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076939-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076939-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076939-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076939-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076939-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076939-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076939-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076939-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076939-004 | AB | 1 | d8e5a09893c0… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16252-528 | Pravastatin sodium | Pravastatin sodium | Actavis Pharma, Inc. | ANDA | Current |
| 21695-178 | Pravastatin Sodium | Pravastatin Sodium | Rebel Distributors Corp | ANDA | Current |
| 21695-179 | Pravastatin Sodium | Pravastatin Sodium | Rebel Distributors Corp | ANDA | Current |
| 21695-180 | Pravastatin Sodium | Pravastatin Sodium | Rebel Distributors Corp | ANDA | Current |
| 50090-2785 | Pravastatin sodium | Pravastatin sodium | A-S Medication Solutions | ANDA | Current |
| 60760-527 | Pravastatin sodium | Pravastatin sodium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-546 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | DirectRX | ANDA | Current |
| 61919-546 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | DirectRX | ANDA | Current |
| 61919-731 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | DirectRX | ANDA | Current |
| 61919-731 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | DirectRX | ANDA | Current |
| 63187-731 | Pravastatin sodium | Pravastatin sodium | Proficient Rx LP | ANDA | Current |
| 63187-731 | Pravastatin sodium | Pravastatin sodium | Proficient Rx LP | ANDA | Current |
| 63187-732 | Pravastatin sodium | Pravastatin sodium | Proficient Rx LP | ANDA | Current |
| 63187-732 | Pravastatin sodium | Pravastatin sodium | Proficient Rx LP | ANDA | Current |
| 63629-1606 | Pravastatin Sodium | Pravastatin Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-3563 | Pravastatin Sodium | Pravastatin Sodium | Bryant Ranch Prepack | ANDA | Current |
| 68071-1917 | Pravastatin sodium | Pravastatin sodium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-2194 | Pravastatin sodium | Pravastatin sodium | NuCare Pharmaceuticals, Inc. | ANDA | Current |