| Product Information |
|
| Registration Number |
DRP-9896-03
|
| Generic Name |
Budesonide
|
| Brand Name |
Budenic
|
| Dosage Strength |
250 mcg/ mL (500 mcg/ 2mL)
|
| Dosage Form |
Suspension for Nebulization
|
| Classification |
Prescription Drug (Rx)
|
| Packaging |
LDPE Plastic Respule x 2 mL in strip of 5's with aluminum pouch (Box of 20's)
|
| Pharmacologic Category |
Corticosteroid
|
| Manufacturer |
AXA Parenterals Ltd.
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Sanimed Pharmaceuticals Inc
|
| Distributor |
Hillcross Prime, Inc.
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
13 December 2023
|
| Expiry Date |
24 June 2025
|