| Product Information |
|
| Registration Number |
DRP-14625
|
| Generic Name |
Gemcitabine (as hydrochloride)
|
| Brand Name |
Spagem
|
| Dosage Strength |
1 g
|
| Dosage Form |
Lyophilized Powder for Injection for I.V. Infusion
|
| Classification |
Prescription (Rx) Drug
|
| Pharmacologic Category |
-
|
| Packaging |
Type I clear colourless glass vial with 20 mm gray bromobutyl rubber stopper and german blue coloured flip off aluminum seal (Box of 1's) al (Box of 1's)
|
| Manufacturer |
SP Accure Labs Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Hexagon Pharmaceuticals
|
| Distributor |
Hexagon Pharmaceuticals
|
| Application Type |
Initial
|
| Issuance Date |
07 November 2023
|
| Expiry Date |
07 November 2028
|