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Radotrace - Philippines FDA Drug Approval Details

Approvals/Philippines FDA/Radotrace

Approved

STANDARD

Radotrace

XL LABORATORIES PVT. LTD.🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: 7d51578f5af10a88
Company: XL LABORATORIES PVT. LTD.
Type: Standard

Approval Details

Approval Id: 7d51578f5af10a88
Drug Approval Philippines Name: Radotrace
Product Name: Radotrace
Registration Number: DRP-5087-06
Brand Name: Radotrace
Generic Name: Racecadotril
Dosage Form: Powder For Oral Suspension
Dosage Strength: 30 mg/ sachet
Manufacturer: XL LABORATORIES PVT. LTD.
Importer: Ambica International Trading Corp.
Distributor: Prodrom Nutritionals, Incorporated
Issuance Date: 31 May 2019
Expiry Date: 11 February 2029
Pharmacologic Category: Anti-diarrheal
Classification: Prescription Drug (RX)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

7d51578f5af10a88

Type

Standard

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