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Approvals/Philippines FDA/Amkalon

Approved

STANDARD

Amkalon

Norris Medicines Ltd.🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: e539a5a6c9e7c01d
Company: Norris Medicines Ltd.
Type: Standard

Approval Details

Approval Id: e539a5a6c9e7c01d
Drug Approval Philippines Name: Amkalon
Product Name: Amkalon
Registration Number: DRP-4552-01
Brand Name: Amkalon
Generic Name: Amikacin (As Sulphate)
Dosage Form: Solution For Inejction
Dosage Strength: 125 mg/mL (250 mg/2 mL)
Manufacturer: Norris Medicines Ltd.
Importer: MedEthix, Inc.
Distributor: Vivilon Pharmaceuticals Inc.
Issuance Date: 26 February 2023
Expiry Date: 26 July 2028
Pharmacologic Category: Antibacterial (Aminoglycoside)
Classification: Prescription Drug (RX)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

e539a5a6c9e7c01d

Type

Standard

Back to Philippines FDA Approvals

Amkalon - Philippines FDA Drug Approval Details