| Product Information |
|
| Registration Number |
DRP-13999
|
| Generic Name |
Gemcitabine (As Hydrochloride)
|
| Brand Name |
Gem Pan 200
|
| Dosage Strength |
200 mg
|
| Dosage Form |
Lyophilized Powder for IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
10 mL USP Type-1 Flint Fiolax Tubular Glass vial with flat bottom stoppered with 20 mm Single Leg Lyo Grey Bromobutyl Rubber stopper sealed with 20 mm Aluminium Flip-off seal. Each individual vial is packed in mono carton. Each carton contains one prescribing information leaflet.
|
| Manufacturer |
Panacea Biotec Ltd.
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Medinova Pharmaceutical Inc.
|
| Distributor |
Medinova Pharmaceutical Inc.
|
| Application Type |
Initial
|
| Issuance Date |
01 June 2023
|
| Expiry Date |
01 June 2028
|