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Ursolec - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Ursolec
Approved
STANDARD
Ursolec
Opsonin Pharma Limited
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
900bf7681d0e7abc
Company
Opsonin Pharma Limited
Type
Standard
Approval Details
Approval Id
900bf7681d0e7abc
Drug Approval Philippines Name
Ursolec
Product Name
Ursolec
Registration Number
DRP-8109-01
Brand Name
Ursolec
Generic Name
Ursodeoxycholic Acid
Dosage Form
Film-Coaed Tablet
Dosage Strength
300 mg
Manufacturer
Opsonin Pharma Limited
Importer
Jazmark Pharmaceutical
Distributor
All-Bio Pharma, Inc.
Issuance Date
29 April 2025
Expiry Date
19 August 2026
Pharmacologic Category
Bile Therapy
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
900bf7681d0e7abc
Type
Standard
Back to Philippines FDA Approvals