| Product Information |
|
| Registration Number |
DR-XY47736
|
| Generic Name |
Zoledronic acid (as monohydrate)
|
| Brand Name |
Myzole
|
| Dosage Strength |
4 mg/5 mL
|
| Dosage Form |
Concentrate Solution for IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Biphosphanates
|
| Packaging |
5 mL USP Type I flint clear glass vial with grey
bromobutyl rubber stopper and maroon red aluminium maroon red flip-off seal (Box of 1's)
|
| Manufacturer |
Mylan Laboratories Limited (Specialty Formulation
Facility)
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Mylan Philippines Inc.
|
| Distributor |
Mylan Philippines Inc.
|
| Application Type |
Initial
|
| Issuance Date |
22 February 2022
|
| Expiry Date |
22 February 2027
|