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ENSET-8 - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
ENSET-8
Approved
STANDARD
ENSET-8
Stallion Laboratories Pvt. Ltd.
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
fec5fc73f01a65f3
Company
Stallion Laboratories Pvt. Ltd.
Type
Standard
Approval Details
Approval Id
fec5fc73f01a65f3
Drug Approval Philippines Name
ENSET-8
Product Name
ENSET-8
Registration Number
DRP-6609
Brand Name
ENSET-8
Generic Name
Ondansetron (as hydrochloride dihydrate)
Dosage Form
Film-Coated Tablet
Dosage Strength
8 mg
Manufacturer
Stallion Laboratories Pvt. Ltd.
Importer
Ambica International Corporation
Distributor
Caledan Pharma Corp.
Issuance Date
25 March 2025
Expiry Date
30 March 2037
Pharmacologic Category
Antiemetic (5-HT3-Receptor Antagonist)
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
fec5fc73f01a65f3
Type
Standard
Back to Philippines FDA Approvals