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None - Philippines FDA Drug Approval Details
Approvals
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Philippines FDA
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None
Approved
STANDARD
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Shilpa Medicare Limited (Unit-4, Pharmaceutical Formulations SEZ)
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
8f22819ef6767a99
Company
Shilpa Medicare Limited (Unit-4, Pharmaceutical Formulations SEZ)
Type
Standard
Approval Details
Approval Id
8f22819ef6767a99
Drug Approval Philippines Name
None
Product Name
None
Registration Number
DR-XY48715
Brand Name
None
Generic Name
Azacitidine
Dosage Form
Lyophilized Powder for Injection (IV/SC)
Dosage Strength
100 mg
Manufacturer
Shilpa Medicare Limited (Unit-4, Pharmaceutical Formulations SEZ)
Importer
Biocare Lifesciences, Inc.
Distributor
Biocare Lifesciences, Inc.
Issuance Date
28 April 2023
Expiry Date
28 April 2028
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
8f22819ef6767a99
Type
Standard
Back to Philippines FDA Approvals