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Approvals
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Philippines FDA
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Monte H5
Approved
STANDARD
Monte H5
Hetero Labs Limited
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
0249ef18b8b02b33
Company
Hetero Labs Limited
Type
Standard
Approval Details
Approval Id
0249ef18b8b02b33
Drug Approval Philippines Name
Monte H5
Product Name
Monte H5
Registration Number
DRP-6893
Brand Name
Monte H5
Generic Name
Montelukast (As Sodium)
Dosage Form
Chewable Tablet
Dosage Strength
5mg
Manufacturer
Hetero Labs Limited
Importer
S.M.H.P. Marketing and Consultancy
Distributor
S.M.H.P. Marketing and Consultancy
Company Detail Path
/organization/hetero-labs-limited
Issuance Date
26 May 2022
Expiry Date
21 July 2027
Pharmacologic Category
Leukotriene Receptor Antagonist
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
0249ef18b8b02b33
Type
Standard
Back to Philippines FDA Approvals
Monte H5 - Philippines FDA Drug Approval Details