Optagen

Amanta Healthcare Ltd.🇵🇭 Food and Drug Administration - Philippines

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)

Approved

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

534366d97ce11fad

Type

Standard