| Product Information |
DRP-14002_PI_01.pdf
|
| Registration Number |
DRP-14002
|
| Generic Name |
Ifosfamide
|
| Brand Name |
Fosfalex
|
| Dosage Strength |
1 g
|
| Dosage Form |
Lyophilized Powder for Concentrate for Solution for
IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
USP Type I Amber Vial with Bromobutyl Rubber Stopper and Aluminum Seal with White Flip Off Cap (Box of 1's)
|
| Manufacturer |
Laboratorio Kemex S.A.
|
| Country of Origin |
Argentina
|
| Trader |
N/A
|
| Importer |
Delex Pharma International, Inc.
|
| Distributor |
Delex Pharma International, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
26 September 2023
|
| Expiry Date |
06 June 2028
|