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Affocaine - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Affocaine
Approved
STANDARD
Affocaine
Norris Medicines Limited
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
b495718af080de72
Company
Norris Medicines Limited
Type
Standard
Approval Details
Approval Id
b495718af080de72
Drug Approval Philippines Name
Affocaine
Product Name
Affocaine
Registration Number
DRP-4877-02
Brand Name
Affocaine
Generic Name
Bupivacaine Hydrochloride In 8% Dextrose
Dosage Form
Solution for Spinal Injection
Dosage Strength
5 mg/mL (0.5%)
Manufacturer
Norris Medicines Limited
Importer
MedEthix, Inc.
Distributor
Sel-J Pharma Corporation
Issuance Date
29 May 2023
Expiry Date
28 June 2028
Pharmacologic Category
Local Anesthetic
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
b495718af080de72
Type
Standard
Back to Philippines FDA Approvals