| Product Information |
|
| Registration Number |
DRP-12505
|
| Generic Name |
Acetylcysteine
|
| Brand Name |
Respifar
|
| Dosage Strength |
100 mg/mL
|
| Dosage Form |
Solution For Inhalation
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Mucolytic
|
| Packaging |
3 mL Type I clear and colorless borosilicate glass ampoule (Box of 5's in PVC tray)
|
| Manufacturer |
PT. Pratapa Nirmala
|
| Country of Origin |
Indonesia
|
| Trader |
N/A
|
| Importer |
Exa Life Care Pharma, Inc.
|
| Distributor |
Exa Life Care Pharma, Inc.
|
| Application Type |
Initial (Re-application)
|
| Issuance Date |
22 August 2022
|
| Expiry Date |
22 August 2027
|