| Product Information |
|
| Registration Number |
DR-XY47158
|
| Generic Name |
Gemcitabine (as Hydrochloride)
|
| Brand Name |
Bagogen
|
| Dosage Strength |
1 g
|
| Dosage Form |
Lyophilized Powder for Solution for IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic Agent (Pyrimidine Analogue)
|
| Packaging |
50-mL capacity USP Type I Clear glass vial with bromobutyl rubber stopper and red flip-off aluminum seal (Box of 1's)
|
| Manufacturer |
Laboratorio Kemex S.A.
|
| Country of Origin |
Argentine
|
| Trader |
Bioprofarma Bagó S.A.
|
| Importer |
Health Y Wonders Corp.
|
| Distributor |
N/A
|
| Application Type |
Initial
|
| Issuance Date |
22 April 2021
|
| Expiry Date |
22 April 2026
|