Application 078872
- Type
- ANDA
- Sponsor
- PAR PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUVASTATIN SODIUM | FLUVASTATIN SODIUM | TABLET, EXTENDED RELEASE; ORAL | 80MG | No | No |
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 |
|---|---|---|---|---|---|---|
| Fluvastatin Sodium | FLUVASTATIN SODIUM | Lannett Company, Inc. | 3565bfd3-ef9f-456d-b4be-a294a7a0f01c | 2026-03-18 | Warnings, Adverse reactions | Fluvastatin Sodium FLUVASTATIN SODIUM |
| Fluvastatin Sodium | FLUVASTATIN SODIUM | Teva Pharmaceuticals USA, Inc. | cc55110f-1ad6-4f97-840d-62b3a5ac415a | 2024-09-16 | Warnings, Adverse reactions | Fluvastatin Sodium FLUVASTATIN SODIUM |
| FLUVASTATIN SODIUM ER | FLUVASTATIN SODIUM | Sandoz Inc | 5ab4296c-87c2-4c64-b218-d620eef51310 | 2024-01-31 | Warnings, Adverse reactions | FLUVASTATIN SODIUM |
| Lescol XL | FLUVASTATIN SODIUM | Sandoz Inc | 726ea2db-f1b0-4b73-a515-02157db88a42 | 2023-12-13 | Warnings, Adverse reactions | FLUVASTATIN SODIUM |
| Fluvastatin Sodium | FLUVASTATIN | Mylan Pharmaceuticals Inc. | d0a7247c-5d83-4bc1-840f-c58314d14195 | 2020-08-20 | Warnings, Adverse reactions | Fluvastatin Sodium |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31394 | ORIG | 2009-09-23 |