| Product Information |
|
| Registration Number |
DRP-13075-01
|
| Generic Name |
Gemcitabine (as Hydrochloride)
|
| Brand Name |
Zitabin-200
|
| Dosage Strength |
200 mg
|
| Dosage Form |
Lyophilized Powder for Injection (IV Infusion)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
-
|
| Packaging |
10 mL USP Type I glass vial with grey bromobutyl rubber stopper and light purple flip-off cap (Box of 1's)
|
| Manufacturer |
Bruck Pharma Private Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Kaufman Pharma Inc.
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
26 January 2023
|
| Expiry Date |
28 November 2027
|