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Urogen - Philippines FDA Drug Approval Details

Approvals/Philippines FDA/Urogen

Approved

STANDARD

Urogen

Globela Pharma Private Limited🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: 8636209ca69095b0
Company: Globela Pharma Private Limited
Type: Standard

Approval Details

Approval Id: 8636209ca69095b0
Drug Approval Philippines Name: Urogen
Product Name: Urogen
Registration Number: DRP-10763-03
Brand Name: Urogen
Generic Name: Dutasteride + Tamsulosin hydrochloride
Dosage Form: Capsule
Dosage Strength: 500 mcg/400 mcg
Manufacturer: Globela Pharma Private Limited
Importer: AMB HK Enterprises Inc.
Distributor: Genace Pharma Distributor
Issuance Date: 27 May 2022
Expiry Date: 16 November 2026
Pharmacologic Category: Alpha-adrenoreceptor Antagonists
Classification: Prescription Drug (Rx)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

8636209ca69095b0

Type

Standard

Back to Philippines FDA Approvals