Avanafil Tablets Technical Specification:
| Product Name: | Avanafil Tablet 100mg |
| Brand Name: | Generic |
| Strength: | 50mg, 100mg, 200mg |
| Dosage Form: | Tablets (Film-Coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 4s, 10s, 30s |
| 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: | For erectile dysfunction & phosphodiesterase 5 (PDE5) inhibitors |
| Indication: | Avanafil is used to treat men who have erectile dysfunction (also called sexual impotence). Avanafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. |
| Storage: | Store in cool, dry place, below 30℃ temperature. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Avanafil Tablet USP 50mg
Avanafil Tablet USP 100mg
Avanafil Tablet USP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film-coated tablet contains:
Avanafil USP…….100mg
Excipients……q.s.
Color: Red Oxide of Iron USP-NF, Lake Indigo Carmine
THERAPEUTIC INDICATIONS:
Avanafil is used to treat men who have erectile dysfunction (also called sexual impotence). Avanafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors.
CAUTION:
Keep out of reach of children.
STORAGE:
Storage: Store in cool, dry place, below 30℃ temperature.