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Dabitrin 110 - Philippines FDA Drug Approval Details
Approvals
/
Philippines FDA
/
Dabitrin 110
Approved
STANDARD
Dabitrin 110
Hetero Labs Limited (Unit III)
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
da629f34368bc04e
Company
Hetero Labs Limited (Unit III)
Type
Standard
Approval Details
Approval Id
da629f34368bc04e
Drug Approval Philippines Name
Dabitrin 110
Product Name
Dabitrin 110
Registration Number
DRP-16486
Brand Name
Dabitrin 110
Generic Name
Dabigatran etexilate (as mesilate)
Dosage Form
Capsule
Dosage Strength
110 mg
Manufacturer
Hetero Labs Limited (Unit III)
Importer
Camber Pharmaceuticals, Inc.
Distributor
Camber Pharmaceuticals, Inc.
Importer Detail Path
/organization/camber-pharmaceuticals-inc
Distributor Detail Path
/organization/camber-pharmaceuticals-inc
Issuance Date
26 March 2025
Expiry Date
25 March 2030
Pharmacologic Category
Antithrombotic Agent (Direct Thrombin Inhibitor)
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
da629f34368bc04e
Type
Standard
Back to Philippines FDA Approvals