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Betalex - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Betalex
Approved
STANDARD
Betalex
United Biotech Pvt. Ltd.
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
1077d9ea530309b0
Company
United Biotech Pvt. Ltd.
Type
Standard
Approval Details
Approval Id
1077d9ea530309b0
Drug Approval Philippines Name
Betalex
Product Name
Betalex
Registration Number
DR-XY48744
Brand Name
Betalex
Generic Name
Labetalol Hydrochloride
Dosage Form
Solution for Injection (IV)
Dosage Strength
5 mg/mL (20 mg/4 mL)
Manufacturer
United Biotech Pvt. Ltd.
Importer
Delex Pharma International, Inc.
Distributor
Delex Pharma International, Inc.
Issuance Date
25 May 2023
Expiry Date
25 May 2028
Classification
Prescription (Rx) Drug
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
1077d9ea530309b0
Type
Standard
Back to Philippines FDA Approvals