| Product Information |
|
| Registration Number |
DRP-8739
|
| Generic Name |
Temozolomide
|
| Brand Name |
Gliotem 100
|
| Dosage Strength |
100 mg
|
| Dosage Form |
Hard Gelatin Capsule
|
| Classification |
Prescription Drug (Rx)
|
| Packaging |
Cold formed Alu-Alu (OPA/Alu/PVC laminate foil and Paper/PET/Alu lidding foil) Blister Pack x 5's (Box of 5's)
|
| Pharmacologic Category |
Antineoplastic Agent
|
| Manufacturer |
Sun Pharmaceutical Industries Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Sun Pharma Philippines, Inc.
|
| Distributor |
Sun Pharma Philippines, Inc.
|
| Application Type |
Initial (Variation)
|
| Issuance Date |
15 April 2024
|
| Expiry Date |
15 April 2029
|