| Product Information |
|
| Registration Number |
DRP-11996
|
| Generic Name |
Fluticasone propionate
|
| Brand Name |
Dalman
|
| Dosage Strength |
50 mcg per actuation (0.05% w/w)
|
| Dosage Form |
Aqueous Suspension.
for Inhalation (Nasal Spray)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Corticosteroid
|
| Packaging |
20 mL- capacity white HDPE bottle with crimp-on
metered-dose micro pump, nasal actuator and dust protective cap x 120 actuations (Box of 1 bottle)
|
| Manufacturer |
Drogsan Ilaclari Sanayi ve Ticaret A.S.
|
| Country of Origin |
Turkey
|
| Trader |
N/A
|
| Importer |
Orange Biotec Inc.
|
| Distributor |
Orange Biotec Inc.
|
| Application Type |
Initial (Reconstruction)
|
| Issuance Date |
31 July 2024
|
| Expiry Date |
01 August 2029
|