| Product Information |
|
| Registration Number |
DRP-13962
|
| Generic Name |
Budesonide
|
| Brand Name |
Budenase 0.25
|
| Dosage Strength |
125mcg/mL (0.25 mg/2mL)
|
| Dosage Form |
Suspension for Nebulization
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
LDPE Plastic Respule x 2 mL in strip of 5's with aluminum pouch (Box of 30's)
|
| Manufacturer |
Cipla Limited (Unit I)
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
SMHP Pharmaceuticals Incorporated
|
| Distributor |
SMHP Pharmaceuticals Incorporated
|
| Application Type |
Initial
|
| Issuance Date |
26 May 2023
|
| Expiry Date |
26 May 2028
|