| Product Information |
|
| Registration Number |
DRP-12854
|
| Generic Name |
Cefuroxime (as axetil)
|
| Brand Name |
Philcef-DS 250
|
| Dosage Strength |
250mg/5mL
|
| Dosage Form |
Powder for Oral Suspension
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antibacterial (Cephalosporin)
|
| Packaging |
Translucent white HPDE Bottle with PP cap and measuring cup x 30 mL, 60 mL, and 70 mL (Box of 1's)
|
| Manufacturer |
NGB Laboratories Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
FSPC Pharmaceuticals, Inc.
|
| Distributor |
FSPC Pharmaceuticals, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
28 October 2022
|
| Expiry Date |
28 October 2027
|