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Approvals
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Philippines FDA
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Kotifen
Approved
STANDARD
Kotifen
Azarias Pharmaceutical Laboratories Inc
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
b5ef1cdbb3913f97
Company
Azarias Pharmaceutical Laboratories Inc
Type
Standard
Approval Details
Approval Id
b5ef1cdbb3913f97
Drug Approval Philippines Name
Kotifen
Product Name
Kotifen
Registration Number
DRP-5334-01
Brand Name
Kotifen
Generic Name
Ketotifen (as hydrogen fumarate)
Dosage Form
Tablet
Dosage Strength
1 mg
Manufacturer
Azarias Pharmaceutical Laboratories Inc
Distributor
Konzept Convenience and Drug Store Corp.
Issuance Date
29 June 2024
Expiry Date
10 June 2029
Pharmacologic Category
Anti-histamine
Classification
Prescription Drug (Rx)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
b5ef1cdbb3913f97
Type
Standard
Back to Philippines FDA Approvals
Kotifen - Philippines FDA Drug Approval Details