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Spalax - Philippines FDA Drug Approval Details

Approvals/Philippines FDA/Spalax

Approved

STANDARD

Spalax

Sapphire Lifesciences Pvt. Ltd.🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: e1052ebc03bf42ed
Company: Sapphire Lifesciences Pvt. Ltd.
Type: Standard

Approval Details

Approval Id: e1052ebc03bf42ed
Drug Approval Philippines Name: Spalax
Product Name: Spalax
Registration Number: DRP-8477-02
Brand Name: Spalax
Generic Name: Hyoscine N-Butylbromide
Dosage Form: Film-Coated Tablet
Dosage Strength: 10 mg
Manufacturer: Sapphire Lifesciences Pvt. Ltd.
Importer: Nelpa Lifesciences, Inc
Distributor: Kaufmann Pharma Inc
Issuance Date: 26 September 2023
Expiry Date: 16 May 2027
Pharmacologic Category: Anticholinergic
Classification: Prescription Drug (Rx)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

e1052ebc03bf42ed

Type

Standard

Back to Philippines FDA Approvals