| Product Information |
|
| Registration Number |
DR-XY46385
|
| Generic Name |
Gemcitabine (As Hydrochloride)
|
| Brand Name |
Zytogem
|
| Dosage Strength |
1g
|
| Dosage Form |
Lyophilized Powder for IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
60-mL clear, colorless USP Type I glass vial with grey
chlorobutyl rubber stopper and aluminum seal (Box of 1’s)
|
| Manufacturer |
Ildong Pharmaceutical Co., Ltd.
|
| Country of Origin |
Korea
|
| Trader |
N/A
|
| Importer |
International Apex Pharmaceuticals, Inc.
|
| Distributor |
N/A
|
| Application Type |
Initial
|
| Issuance Date |
21 May 2021
|
| Expiry Date |
25 June 2025
|