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Kabimidine - Philippines FDA Drug Approval Details

Approvals/Philippines FDA/Kabimidine

Approved

STANDARD

Kabimidine

Gland Pharma Limited🇵🇭 Food and Drug Administration - Philippines

Approval Date: Jul 14, 2025
Approval ID: 2fe205580a894e03
Company: Gland Pharma Limited
Type: Standard

Approval Details

Approval Id: 2fe205580a894e03
Drug Approval Philippines Name: Kabimidine
Product Name: Kabimidine
Registration Number: DR-XY47664
Brand Name: Kabimidine
Generic Name: Dexmedetomidine (as Hydrochloride)
Dosage Form: Sterile Solution for I.V. Injection
Dosage Strength: 100 mcg/mL (200 mcg/ 2 mL)
Manufacturer: Gland Pharma Limited
Importer: Fresenius Kabi Philippines, Inc.
Company Detail Path: /organization/0f49c73bd01f4b0d/gland-pharma-limited
Issuance Date: 31 July 2024
Expiry Date: 11 January 2027
Pharmacologic Category: Hypnotic/ Sedative
Classification: Prescription Drug (Rx)

Active Ingredients

Approved

Quick Info

Agency

Philippines FDA

Country

🇵🇭

Approval Date

Jul 14, 2025

Approval ID

2fe205580a894e03

Type

Standard

Back to Philippines FDA Approvals