| Product Information |
|
| Registration Number |
DRP-13522
|
| Generic Name |
Docetaxel (as trihydrate)
|
| Brand Name |
Chetax-80
|
| Dosage Strength |
40 mg/mL (80 mg/2 mL)
|
| Dosage Form |
Concentrate Solution for IV
Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic (Taxane)
|
| Packaging |
USP Type I clear moulded glass vial with grey. bromobutyl rubber stopper and yellow flip off seal x 2 mL USP Type I clear moulded glass vial with grey bromobutyl rubber stopper and white flip off seal x 6 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 |
03 March 2028
|