| Product Information |
|
| Registration Number |
DRP-12591-03
|
| Generic Name |
Cefixime (as trihydrate)
|
| Brand Name |
Zelpis-100
|
| Dosage Strength |
100 mg/5 mL (20 mg/mL)
|
| Dosage Form |
Powder for Oral Suspension
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antibacterial (Cephalosporin)
|
| Packaging |
HDPE plastic bottle x 60 mL (Box of 1’s)
|
| Manufacturer |
Globela Laboratories Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
AMB HK Enterprises Inc.
|
| Distributor |
Kaufmann Pharma Inc
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
14 December 2023
|
| Expiry Date |
19 September 2027
|