| Product Information |
|
| Registration Number |
DRP-10972-01
|
| Generic Name |
Budesonide
|
| Brand Name |
Broncort
|
| Dosage Strength |
250 mcg / mL (500 mcg / 2 mL)
|
| Dosage Form |
Suspension for Nebulization
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Corticosteroid
|
| Packaging |
2 mL Polypropylene Ampoule x 5's in aluminum pouch (Box of 30's) and 7's in aluminum pouch (Box of 35's)
|
| Manufacturer |
Althea Pharma Pvt. Ltd
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Ollen Pharma Trading Inc.
|
| Distributor |
Kaufmann Pharma Inc.
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
13 September 2023
|
| Expiry Date |
29 December 2026
|