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None - Philippines FDA Drug Approval Details
Approvals
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Philippines FDA
/
None
Approved
STANDARD
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Wockhardt Limited
🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
5786e83a0321bf80
Company
Wockhardt Limited
Type
Standard
Approval Details
Approval Id
5786e83a0321bf80
Drug Approval Philippines Name
None
Product Name
None
Registration Number
BRP-054-02
Brand Name
None
Generic Name
Biphasic Isophane Insulin Human (Recombinant DNA Origin)
Dosage Form
Suspension for Injection (SC) (30% Regular Insulin Human/70% Isophane Insulin Human)
Dosage Strength
100 IU/mL
Manufacturer
Wockhardt Limited
Importer
Ambica International Corporation
Distributor
Ambicare Pharmaceuticals Inc.
Company Detail Path
/organization/wockhardt-limited
Issuance Date
15 November 2023
Expiry Date
10 February 2029
Pharmacologic Category
Intermediate-Acting Insulin
Classification
Prescription Drug (RX)
Active Ingredients
Approved
Quick Info
Agency
Philippines FDA
Country
🇵🇭
Approval Date
Jul 14, 2025
Approval ID
5786e83a0321bf80
Type
Standard
Back to Philippines FDA Approvals