| Items | Drug Registration information |
|---|---|
| ID | 2164 |
| No | 2164 |
| Brand Name | BENICLAV 457 |
| Ingredients | EACH 5 ML CONTAINS: AMOXICILLIN TRIHYDRATE USP EQ. TO AMOXICILLIN ANHYDROUS 400 MG, DILUTED POTASSIUM CLAVULANATE BP EQ .TO CLAVULANIC ACID BP 57 MG |
| Dosage Form | ORAL SUSPENSION |
| Primary Packaging | BOTTLE |
| Storage | |
| Shelf Life | 18 MONTHS |
| Pack Size | 60 ML/BOTTLE |
| Dispensing Category | |
| ATC Classification | |
| Pharmaceutical Class | |
| Indications | FOR THE TREATMENT OF THE FOLLOWING INFECTIONS IN ADULTS AND CHILDREN : ACUTE BACTERIAL SINUSITIS, ACUTE OTITIS MEDIA , ACUTE EXACERBATIONS OF CHRONIC BRONCHITIS, COMMUNITY ACQUIRED PNEUMONIA, CYSTITIS, PYELONEPHRITIS, SKIN AND SOFT TISSUE INFECTION, BONE AND JOINT INFECTION. |
| Contraindications | |
| Side Effects | |
| Unit Price | |
| EDL | NULL |
| Description | OFF WHITE GRANULAR POWDER CONVERTED IN TO ORANGE COLORED SUSPENSION AFTER ADDITION OF WATER AND MAKE UP TO VOLUME 60ML |
| Note | |
| License Owner | POUNSAB PHARMA CO.,LTD |
| Manufacturer | BAROQUE PHARMACEUTICALS PVT LTD. |
| Country | INDIA |
| Import Registration No | |
| Import Registration Date | |
| Activity | CERTIFICATE RELEASED |
| Applied Date | |
| FDD Registration No | 06 I 4463/18 |
| FDD Registration Date | 07/07/2025 |
| Expiry Date | 06/07/2030 |