APPLICATION
ANDA091465
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-14
LATEST ACTION
2020-06-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXMEDETOMIDINE HYDROCHLORIDEDiscontinued
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · INJECTABLE · INJECTION
Approval history
2020-06-22Labeling · Supplement 2 · standardAP
2016-06-14OriginalAP
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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