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Optagen - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Optagen
Approved
STANDARD
Optagen
Amanta Healthcare Ltd.
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
534366d97ce11fad
Company
Amanta Healthcare Ltd.
Type
Standard
Approval Details
Approval Id
534366d97ce11fad
Drug Approval Philippines Name
Optagen
Product Name
Optagen
Registration Number
DR-XY41926
Brand Name
Optagen
Generic Name
Gentamicin (As Sulfate) + Dexamethasone Phosphate (As Sodium Phosphate)
Dosage Form
Ophthalmic Solution
Dosage Strength
3 mg/1 mg per mL
Manufacturer
Amanta Healthcare Ltd.
Importer
Endure Medical, Inc.
Distributor
Endure Medical, Inc.
Issuance Date
26 October 2022
Expiry Date
18 April 2028
Pharmacologic Category
Corticosteroids and Antiinfectives in Combination
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
534366d97ce11fad
Type
Standard
Back to Philippines FDA Approvals