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FDA NDA · NDA206628

DEXMEDETOMIDINE

Sponsor: HQ SPCLT PHARMA

APPLICATION
NDA206628
TYPE
NDA
ORIGINAL APPROVAL
2015-10-21
LATEST ACTION
2026-05-01
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

DEXMEDETOMIDINE HYDROCHLORIDE · ReferencePrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · SOLUTION · INTRAVENOUS
DEXMEDETOMIDINE HYDROCHLORIDE · ReferencePrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) · SOLUTION · INTRAVENOUS
DEXMEDETOMIDINE HYDROCHLORIDE · ReferencePrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · SOLUTION · INTRAVENOUS
DEXMEDETOMIDINE HYDROCHLORIDE · ReferencePrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-05-01Labeling · Supplement 24 · standard — Letter ↗AP
2024-03-21Labeling · Supplement 5 · standard — Letter ↗AP
2021-06-07Manufacturing (CMC) · Supplement 17 — Letter ↗AP
2016-09-19Efficacy · Supplement 2 · standard — Letter ↗AP
2016-02-09Manufacturing (CMC) · Supplement 1 · standardAP
2015-10-21Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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.

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