| Product Information |
DRP-11689_PI_01.pdf
|
| Registration Number |
DRP-11689
|
| Generic Name |
Flourouracil
|
| Brand Name |
Fluoracilex
|
| Dosage Strength |
50 mg/mL (500 mg/10 mL)
|
| Dosage Form |
Solution for I.V.
Injection/Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic Agent (Pyrimidine Analogue)
|
| Packaging |
10 mL (net content) USP Type I Clear and Colorless
Glass Vial with Bromobutyl Rubber Stopper and Aluminum Seal with White Plastic Flip-Off Cap (Box of 5's)
|
| Manufacturer |
Laboratorio Kemex S.A.
|
| Country of Origin |
Argentine Republic
|
| Trader |
|
| Importer |
Delex Pharma International, Inc.
|
| Distributor |
Delex Pharma International, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
13 April 2022
|
| Expiry Date |
13 April 2027
|