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Amisac-500 - Philippines FDA Drug Approval Details

Approvals/Philippines FDA/Amisac-500

Approved

STANDARD

Amisac-500

Akums Drugs & Pharmaceuticals Ltd. (Plant III - Injectables)🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: 9afee1a150a27e7b
Company: Akums Drugs & Pharmaceuticals Ltd. (Plant III - Injectables)
Type: Standard

Approval Details

Approval Id: 9afee1a150a27e7b
Drug Approval Philippines Name: Amisac-500
Product Name: Amisac-500
Registration Number: DRP-8835
Brand Name: Amisac-500
Generic Name: Amikacin
Dosage Form: Solution for Injection (IM/IV)
Dosage Strength: 500mg/2mL (250mg/Ml)
Manufacturer: Akums Drugs & Pharmaceuticals Ltd. (Plant III - Injectables)
Trader: Unosource Pharma Ltd.
Importer: Ambica International Trading Corporation
Issuance Date: 24 June 2024
Expiry Date: 29 April 2030
Pharmacologic Category: Antibacterials (Aminoglycosides)
Classification: Prescription Drug (Rx)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

9afee1a150a27e7b

Type

Standard

Back to Philippines FDA Approvals