| Product Information |
|
| Registration Number |
DR-XY48246
|
| Generic Name |
Docetaxel
|
| Brand Name |
Belcytere
|
| Dosage Strength |
20 mg/mL (80 mg/4mL) (160 mg/8 mL)
|
| Dosage Form |
Solution for
Injection (IV Infusion)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
5 mL Type I Clear Glass Vial Sealed with Gray Rubber
Stopper and Blue Aluminum Flip-Off Seal Cap x 1mL and 4 mL (Net content) 15 mL Type I Clear Glass Vial Sealed with Gray Rubber Stopper and Blue Aluminum Flip-Off Seal Cap x 8 mL (Net content)
|
| Manufacturer |
Biolyse Pharma Corporation
|
| Country of Origin |
Canada
|
| Trader |
N/A
|
| Importer |
Belcynor Pharmaceuticals, Inc.
|
| Distributor |
N/A
|
| Application Type |
Initial (Re-application]
|
| Issuance Date |
29 July 2022
|
| Expiry Date |
29 July 2027
|