APPLICATION
ANDA218112
TYPE
ANDA
ORIGINAL APPROVAL
2024-09-24
LATEST ACTION
2024-09-24
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
DEXMEDETOMIDINE HYDROCHLORIDEPrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) · SOLUTION · INTRAVENOUS
DEXMEDETOMIDINE HYDROCHLORIDEPrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) · SOLUTION · INTRAVENOUS
Approval history
2024-09-24UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.