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Urgal-300 - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Urgal-300
Approved
STANDARD
Urgal-300
Sydler Remedies Private Limited
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
d3998c355350af15
Company
Sydler Remedies Private Limited
Type
Standard
Approval Details
Approval Id
d3998c355350af15
Drug Approval Philippines Name
Urgal-300
Product Name
Urgal-300
Registration Number
DRP-4650
Brand Name
Urgal-300
Generic Name
Ursodeoxycholic acid
Dosage Form
Tablet
Dosage Strength
300 mg
Manufacturer
Sydler Remedies Private Limited
Importer
MedEthix, Inc.
Distributor
Kaufmann Pharma Inc.
Issuance Date
27 April 2025
Expiry Date
19 December 2031
Pharmacologic Category
Bile Acid Derivative
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
d3998c355350af15
Type
Standard
Back to Philippines FDA Approvals