| Product Information |
|
| Registration Number |
DRP-6441-02
|
| Generic Name |
Fluorouracil
|
| Brand Name |
Urabene
|
| Dosage Strength |
50 mg/mL
|
| Dosage Form |
Solution For Injection (IV)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antineoplastic (Cell Cycle-Specific Agent)
|
| Packaging |
USP Type I Amber Glass Ampoule x 5 mL / (Box of 5's)
USP Type I Amber Glass Ampoule x 10 mL / (Box of 5's)
|
| Manufacturer |
Celon Laboratories Private Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
I.E. Medica, Inc
|
| Distributor |
Medethix, Inc.
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
12 June 2024
|
| Expiry Date |
21 January 2029
|