| Product Information |
|
| Registration Number |
DRP-9170-05
|
| Generic Name |
Budesonide
|
| Brand Name |
Broncort
|
| Dosage Strength |
250 mcg/mL (500 mcg/2 mL)
|
| Dosage Form |
Suspension for Nebulization
|
| Classification |
Prescription Drug (Rx)
|
| Packaging |
2 mL LDPE ampoule x 5's in aluminum pouch (Box of 25's)
|
| Pharmacologic Category |
Glucocorticoid
|
| Manufacturer |
Legency Remedies Pvt. Ltd
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Suhitas Pharmaceuticals Inc
|
| Distributor |
Kaufmann Pharma Inc
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
31 December 2023
|
| Expiry Date |
22 September 2025
|