APPLICATION
ANDA201072
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-18
LATEST ACTION
2023-11-28
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
2023-11-28Labeling · Supplement 8 · standardAP
2020-06-16Labeling · Supplement 2 · standardAP
2020-06-16Labeling · Supplement 1 · standardAP
2015-09-18Not 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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