| Product Information |
|
| Registration Number |
DRP-13593
|
| Generic Name |
Zoledronic acid (as monohydrate)
|
| Brand Name |
Sorliv
|
| Dosage Strength |
4mg/5mL
|
| Dosage Form |
Solution for Intravenous Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
5 mL flint tubular USP Type I glass vial stoppered with 20 mm grey bromo butyl omniflex plus coated rubber stopper (RFS) and 20 mm aluminum flip off light blue seal (Box of 1's)
|
| Manufacturer |
Shilpa Medicare Limited, Unit. 4, Pharmaceutical Formulations SEZ
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Ambica International Corporation
|
| Distributor |
Ambica International Corporation
|
| Application Type |
Initial
|
| Issuance Date |
14 March 2023
|
| Expiry Date |
14 March 2028
|