| Product Information |
|
| Registration Number |
DRP-13393
|
| Generic Name |
Gliclazide + Metformin Hydrochloride
|
| Brand Name |
Saphzimet
|
| Dosage Strength |
80 mg/ 500 mg
|
| Dosage Form |
Film-Coated Tablet
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Alu/Alu Blister Pack x 10's (Box of 30's)
|
| Manufacturer |
Sapphire Lifesciences Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Ollen Pharma Trading Inc.
|
| Distributor |
Ollen Pharma Trading Inc.
|
| Application Type |
Initial (Re-application)
|
| Issuance Date |
10 February 2023
|
| Expiry Date |
10 February 2028
|