| Product Information |
|
| Registration Number |
DRP-9896
|
| Generic Name |
Budesonide
|
| Brand Name |
Budexa
|
| Dosage Strength |
250mcg/mL(500mcg/mL)
|
| Dosage Form |
Suspension for Nebulization
|
| Classification |
Prescription (Rx) Drug
|
| 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 |
Sanimed Pharmaceuticals Inc.
|
| Application Type |
Initial (Variation: PCPR Conversion) (Reconstruction)
|
| Issuance Date |
11 January 2024
|
| Expiry Date |
24 June 2025
|