Application 076445
- Type
- ANDA
- Sponsor
- RANBAXY LABS LTD
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 |
|---|---|---|---|---|---|---|---|
| A076445-001 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2007-04-23 | ||
| A076445-002 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | 2007-04-23 | ||
| A076445-003 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | 2007-04-23 | ||
| A076445-004 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | 2007-04-23 |
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 | A076445-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2007-04-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076445-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | 2007-04-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076445-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | 2007-04-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076445-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | 2007-04-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076445-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2007-04-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076445-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | 2007-04-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076445-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | 2007-04-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076445-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | 2007-04-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076445-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2007-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076445-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | 2007-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076445-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | 2007-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076445-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | 2007-04-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076445-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2007-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076445-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | 2007-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076445-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | 2007-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076445-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | 2007-04-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076445-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2007-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076445-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | 2007-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076445-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | 2007-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076445-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | 2007-04-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076445-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2007-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076445-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | 2007-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076445-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | 2007-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076445-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | 2007-04-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076445-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2007-04-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076445-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | 2007-04-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076445-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | 2007-04-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076445-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | 2007-04-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076445-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2007-04-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076445-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | 2007-04-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076445-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | 2007-04-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076445-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | 2007-04-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076445-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2007-04-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076445-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | 2007-04-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076445-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | 2007-04-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076445-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | 2007-04-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076445-001 | PRAVASTATIN SODIUM | 10MG | TABLET / ORAL | 2007-04-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076445-002 | PRAVASTATIN SODIUM | 20MG | TABLET / ORAL | 2007-04-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076445-003 | PRAVASTATIN SODIUM | 40MG | TABLET / ORAL | 2007-04-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076445-004 | PRAVASTATIN SODIUM | 80MG | TABLET / ORAL | 2007-04-23 | 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 | Dr.Reddy's Laboratories Limited | 99cc0546-bb2d-751e-edfd-1c15a1182e0c | 2018-11-21 | Warnings, Adverse reactions | Pravastatin sodium PRAVASTATIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31123 | ORIG | 2007-05-01 |