| Product Information |
DRP-10616_PI_01.pdf
|
| Registration Number |
DRP-10616
|
| Generic Name |
Docetaxel
|
| Brand Name |
Docelex
|
| Dosage Strength |
40mg/mL
|
| Dosage Form |
Concentrate Solution For IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic
|
| Packaging |
USP Type I colorless glass vial with bromobutyl
rubber stopper and white aluminum flip-off seal x 2 mL + USP Type I colorless vial with butyl rubber stopper and white aluminum flip-off seal x 6 mL water for injection (Box of l's)
|
| Manufacturer |
Laboratorio Kemex S.A.
|
| Country of Origin |
Argentine Republic
|
| Trader |
|
| Importer |
Delex Pharma International, Inc.
|
| Distributor |
Delex Pharma International, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
29 October 2021
|
| Expiry Date |
29 October 2026
|