| Product Information |
DRP-9932_PI_01.pdf
|
| Registration Number |
DRP-9932
|
| Generic Name |
Budesonide
|
| Brand Name |
Budecort Respules
|
| Dosage Strength |
500 mcg/mL (1000 mcg/2 mL)
|
| Dosage Form |
Nebulizing Suspension
(Sterile)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
2 mL Sterile single-dose polyethylene ampoule x 5'S in
aluminum pouch (Box of 20's)
|
| Pharmacologic Category |
Drugs for obstructive airway disease (Glucocorticoid)
|
| Manufacturer |
AstraZeneca AB (PET Blow Fill Seal Facility)
|
| Country of Origin |
Sweden
|
| Trader |
|
| Importer |
AstraZeneca Pharmaceuticals (Phils.), Inc.
|
| Distributor |
AstraZeneca Pharmaceuticals (Phils.), Inc.
|
| Application Type |
Initial (Variation)
|
| Issuance Date |
05 August 2022
|
| Expiry Date |
05 August 2027
|