Fluvastatin Sodium Tablets Technical Specification:
| Product Name: | Fluvastatin Sodium Extended Release Tablets |
| Brand Name: | Generic |
| Strength: | 80mg |
| Dosage Form: | Tablets (Film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 14s, 28s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet),SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSC and CTD Dossier |
| Therapeutic use: | Anti-hypercholesterolemia/ HMG-CoA reductase inhibitors |
| Indication: | Fluvastatin is works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. |
| Storage: | Store at 20℃ to 25℃ (69°F to 77°F).(See USP Controlled Room Temperature) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Fluvastatin Sodium 80mg Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each tablet contains:
Fluvastatin Sodium USP (Hydrated form)
Eq. to Fluvastatin ……………………………….80mg
Excipients……q.s.
THERAPEUTIC INDICATIONS:
Fluvastatin is works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.
CAUTION:
Keep out of reach of children.