| Product Information |
|
| Registration Number |
DRP-11315
|
| Generic Name |
Zoledronic acid (as monohydrate)
|
| Brand Name |
Zolefon
|
| Dosage Strength |
4 mg/5 mL
|
| Dosage Form |
Concentrate Solution for IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Bisphosphonate
|
| Packaging |
5 mL USP Class VI round clear plastic type cyclic
olefin polymer (COP) vial with chlorobutyl rubber stopper and red flip-off cap (Box of 1's)
|
| Manufacturer |
Pt. Fonko International Pharmaceuticals
|
| Country of Origin |
Indonesia
|
| Trader |
N/A
|
| Importer |
Glorious Dexa Mandaya, Inc.
|
| Distributor |
Glorious Dexa Mandaya, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
28 February 2022
|
| Expiry Date |
28 February 2027
|