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Approvals
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Philippines FDA
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Xtandi
Approved
STANDARD
Xtandi
Catalent Pharma Solutions, LLC
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
24612c68a12333b6
Company
Catalent Pharma Solutions, LLC
Type
Standard
Approval Details
Approval Id
24612c68a12333b6
Drug Approval Philippines Name
Xtandi
Product Name
Xtandi
Registration Number
DR-XY44002
Brand Name
Xtandi
Generic Name
Enzalutamide
Dosage Form
Softgel Capsule
Dosage Strength
40mg
Manufacturer
Catalent Pharma Solutions, LLC
Importer
Astellas Pharma Philippines, Inc.
Distributor
Astellas Pharma Philippines, Inc.
Company Detail Path
/organization/catalent-pharma-solutions-llc-madison-wisconsin-united-states
Issuance Date
23 May 2022
Expiry Date
12 May 2027
Classification
Prescription Drug (Rx)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
24612c68a12333b6
Type
Standard
Back to Philippines FDA Approvals
Xtandi - Philippines FDA Drug Approval Details