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Onetic 8 - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Onetic 8
Approved
STANDARD
Onetic 8
PT Pratapa Nirmala
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
07d14d27e545a163
Company
PT Pratapa Nirmala
Type
Standard
Approval Details
Approval Id
07d14d27e545a163
Drug Approval Philippines Name
Onetic 8
Product Name
Onetic 8
Registration Number
DRP-11994
Brand Name
Onetic 8
Generic Name
Ondansetron (As Hydrochloride Dihydrate)
Dosage Form
Solution for Injection (I.M./I.V.)
Dosage Strength
2 mg/mL (8 mg/4 mL)
Manufacturer
PT Pratapa Nirmala
Importer
Exa Life Care Pharma, Inc.
Issuance Date
27 May 2022
Expiry Date
27 May 2027
Pharmacologic Category
Antiemetic and Antinauseant
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
07d14d27e545a163
Type
Standard
Back to Philippines FDA Approvals