| Product Information |
|
| Registration Number |
BR-1381
|
| Generic Name |
Calfactant
|
| Brand Name |
Infasurf
|
| Dosage Strength |
35 mg/mL
|
| Dosage Form |
Intratracheal Suspension
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Type I glass vial with grey bromobutyl stopper capped with aluminum center tear-out seal (Box of
l's) [Net content: 3 mL & 6 mL]
|
| Manufacturer |
ONY Biotech Inc.
|
| Country of Origin |
United States of America
|
| Trader |
|
| Importer |
Pacific Healthcare Philippines, Inc.
|
| Distributor |
Pacific Healthcare Philippines, Inc.
|
| Application Type |
Initial (correction)
|
| Issuance Date |
29 July 2022
|
| Expiry Date |
23 November 2026
|