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Infasurf - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Infasurf
Approved
STANDARD
Infasurf
ONY Biotech Inc.
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
d33a8ff6974da139
Company
ONY Biotech Inc.
Type
Standard
Approval Details
Approval Id
d33a8ff6974da139
Drug Approval Philippines Name
Infasurf
Product Name
Infasurf
Registration Number
BR-1381
Brand Name
Infasurf
Generic Name
Calfactant
Dosage Form
Intratracheal Suspension
Dosage Strength
35 mg/mL
Manufacturer
ONY Biotech Inc.
Importer
Pacific Healthcare Philippines, Inc.
Distributor
Pacific Healthcare Philippines, Inc.
Company Detail Path
/organization/ony-biotech-inc
Issuance Date
29 July 2022
Expiry Date
23 November 2026
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
d33a8ff6974da139
Type
Standard
Back to Philippines FDA Approvals