| Product Information |
|
| Registration Number |
DRP-13303
|
| Generic Name |
Docetaxel (as trihydrate)
|
| Brand Name |
Chetax-20
|
| Dosage Strength |
20 mg/0.5 mL
|
| Dosage Form |
Concentrate Solution for Injection I.V.
Infusion
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antineoplastic (Taxane)
|
| Packaging |
USP Type I clear colourless glass vial with bromo
with butyl rubber stopper and grey flip off seal x 0.5 mL + USP Type I clear colourless glass vial with bromo butyl rubber stopper and green flip off seal x 1.5 mL containing Absolute alcohol (as diluent) in a box.
|
| Manufacturer |
ADMAC Lifesciences.
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Orange Biotec Inc.
|
| Distributor |
Orange Biotec Inc.
|
| Application Type |
Initial (Reconstruction)
|
| Issuance Date |
31 July 2024
|
| Expiry Date |
20 February 2029
|