APPLICATION
ANDA202126
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-20
LATEST ACTION
2026-03-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXMEDETOMIDINE HYDROCHLORIDEPrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · INJECTABLE · INJECTION
Approval history
2026-03-20Labeling · Supplement 11 · standardAP
2026-03-20Labeling · Supplement 9 · standardAP
2021-02-19Labeling · Supplement 5 · standardAP
2017-08-25Labeling · Supplement 2 · standardAP
2017-08-25Labeling · Supplement 1 · standardAP
2015-08-20Not Applicable · OriginalAP
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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