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Hepwin 0.5 - Philippines FDA Drug Approval Details

Approvals/Philippines FDA/Hepwin 0.5

Approved

STANDARD

Hepwin 0.5

Mylan Laboratories Limited🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: 444694fb4fcf15f1
Company: Mylan Laboratories Limited
Type: Standard

Approval Details

Approval Id: 444694fb4fcf15f1
Drug Approval Philippines Name: Hepwin 0.5
Product Name: Hepwin 0.5
Registration Number: DR-XY47747
Brand Name: Hepwin 0.5
Generic Name: Entecavir (as monohydrate)
Dosage Form: Film-Coated Tablet
Dosage Strength: 500 mcg
Manufacturer: Mylan Laboratories Limited
Importer: Mylan Philippines, Inc.
Distributor: Mylan Philippines, Inc.
Company Detail Path: /organization/mylan-laboratories-limited
Issuance Date: 28 February 2022
Expiry Date: 28 February 2027
Pharmacologic Category: Antiviral
Classification: Prescription Drug (RX)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

444694fb4fcf15f1

Type

Standard

Back to Philippines FDA Approvals