| Product Information |
|
| Registration Number |
DRP-9660
|
| Generic Name |
Zoledronic Acid
|
| Brand Name |
Zdonate
|
| Dosage Strength |
5mg/100mL
|
| Dosage Form |
Solution for Injection (I.V. Infusion)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Bisphosphonate
|
| Packaging |
100 mL USP Type I clear glass vial with grey bromobutyl rubber stopper and golden red aluminum flip-off seal (Box of 1's)
|
| Manufacturer |
Gland Pharma Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Biocare Lifesciences, Inc.
|
| Distributor |
Biocare Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
27 April 2021
|
| Expiry Date |
27 April 2026
|