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Odomzo - Philippines FDA Drug Approval Details

Approvals/Philippines FDA/Odomzo

Approved

STANDARD

Odomzo

Patheon Inc.🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: b6495ad5d8a922ea
Company: Patheon Inc.
Type: Standard

Approval Details

Approval Id: b6495ad5d8a922ea
Drug Approval Philippines Name: Odomzo
Product Name: Odomzo
Registration Number: DR-XY48898
Brand Name: Odomzo
Generic Name: Sonidegib (as phosphate)
Dosage Form: Capsule
Dosage Strength: 200 mg
Manufacturer: Patheon Inc.
Trader: Sun Pharmaceutical Industries Limited.
Importer: Sun Pharma Philippines, Inc.
Distributor: Sun Pharma Philippines, Inc.
Company Detail Path: /organization/c84eb1e88fb16ad1/patheon-inc
Issuance Date: 31 July 2024
Expiry Date: 05 October 2028
Pharmacologic Category: Antineoplastic Agent (Hedgehog Pathway Inhibitor)
Classification: Prescription Drug (RX)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

b6495ad5d8a922ea

Type

Standard

Back to Philippines FDA Approvals