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Amikacy-125 - Philippines FDA Drug Approval Details

Approvals/Philippines FDA/Amikacy-125

Approved

STANDARD

Amikacy-125

Hiral Labs Limited🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: 3a62b104f94fc6c6
Company: Hiral Labs Limited
Type: Standard

Approval Details

Approval Id: 3a62b104f94fc6c6
Drug Approval Philippines Name: Amikacy-125
Product Name: Amikacy-125
Registration Number: DRP-13498
Brand Name: Amikacy-125
Generic Name: Amikacin (as sulfate)
Dosage Form: Solution for Injection (I.M./I.V.)
Dosage Strength: 125 mg/mL
Manufacturer: Hiral Labs Limited
Importer: Bellus Life Solutions, Inc.
Distributor: Bellus Life Solutions, Inc.
Issuance Date: 28 February 2023
Expiry Date: 28 February 2028
Classification: Prescription Drug (RX)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

3a62b104f94fc6c6

Type

Standard

Back to Philippines FDA Approvals