| Product Information |
|
| Registration Number |
DRP-11743
|
| Generic Name |
Decitabine
|
| Brand Name |
Decbine
|
| Dosage Strength |
50 mg
|
| Dosage Form |
Lyophilized Powder For Injection (I.V.)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic Agent (Pyrimidine Analogue)
|
| Packaging |
20 mL-capacity type I clear and colorless tubular
glass vial with gray bromobutyl rubber stopper and aluminum seal with baby blue polypropylene flip-off cap + 10 mL diluent type I clear and colorless tubular glass vial with gray bromobutyl rubber stopper and aluminum seal with transparent polypropylene flip-off cap placed in a plastic tray (Box of 1's)
|
| Manufacturer |
Sun Pharmaceutical Industries Ltd.
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Sun Pharma Philippines, Inc.
|
| Distributor |
Sun Pharma Philippines, Inc.
|
| Application Type |
Initial (from Monitored Release) (Reconstruction)
|
| Issuance Date |
01 August 2024
|
| Expiry Date |
23 October 2025
|