APPLICATION
ANDA204843
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-18
LATEST ACTION
2021-03-25
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
2021-03-25Labeling · Supplement 1 · standardAP
2019-01-18UNKNOWN · 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.
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