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Rozutor - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Rozutor
Approved
STANDARD
Rozutor
Elpen Pharmaceutical Co., Inc.
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
5f4c46bf5d599e4f
Company
Elpen Pharmaceutical Co., Inc.
Type
Standard
Approval Details
Approval Id
5f4c46bf5d599e4f
Drug Approval Philippines Name
Rozutor
Product Name
Rozutor
Registration Number
DR-XY47787
Brand Name
Rozutor
Generic Name
Rosuvastatin (as calcium)
Dosage Form
Film- Coated Tablet
Dosage Strength
10 mg
Manufacturer
Elpen Pharmaceutical Co., Inc.
Importer
AJ Research & Pharma, Inc..
Distributor
AJ Research & Pharma, Inc..
Company Detail Path
/organization/elpen-pharmaceutical-co-inc
Issuance Date
08 March 2022
Expiry Date
08 March 2027
Pharmacologic Category
Lipid Modifying Agent (HMG CoA inhibitor)
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
5f4c46bf5d599e4f
Type
Standard
Back to Philippines FDA Approvals