| Product Information |
|
| Registration Number |
DR-XY40517
|
| Generic Name |
Docetaxel (as trihydrate)
|
| Brand Name |
Newtaxel-A
|
| Dosage Strength |
40 mg/mL
|
| Dosage Form |
Solution For IV Injection
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
USP Type I colorless vial x 0.5 mL
(active) + USP Type I colorless glass vial x 1.8 mL (diluent) (Box of 1's); and 80 mg/ 2 mL: USP Type I colorless vial x 2 mL (active) + USP Type I colorless glass vial x 7 mL (diluent) (Box of 1's)
|
| Pharmacologic Category |
Antineoplastic
|
| Manufacturer |
Korea United Pharm. Inc.
|
| Country of Origin |
Korea
|
| Trader |
|
| Importer |
Qualimed Pharma Inc.
|
| Distributor |
Qualimed Pharma Inc.
|
| Application Type |
Renewal
|
| Issuance Date |
04 August 2024
|
| Expiry Date |
10 January 2030
|