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Kotrazith - Philippines FDA Drug Approval Details

Approvals/Philippines FDA/Kotrazith

Approved

STANDARD

Kotrazith

Kotra Pharma (M) SDN. BHD🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: af7a65bf51eaa573
Company: Kotra Pharma (M) SDN. BHD
Type: Standard

Approval Details

Approval Id: af7a65bf51eaa573
Drug Approval Philippines Name: Kotrazith
Product Name: Kotrazith
Registration Number: DRP-15868
Brand Name: Kotrazith
Generic Name: Azithromycin (as dihydrate)
Dosage Form: Lyophilized Powder for Injection for I.V. Infusion
Dosage Strength: 500 mg
Manufacturer: Kotra Pharma (M) SDN. BHD
Importer: Bliss Pharma Distribution and Consultancy Corp.
Distributor: Bliss Pharma Distribution and Consultancy Corp.
Issuance Date: 25 September 2024
Expiry Date: 25 September 2029
Pharmacologic Category: Antibacterial (Macrolide)
Classification: Prescription Drug (RX)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

af7a65bf51eaa573

Type

Standard

Back to Philippines FDA Approvals