APPLICATION
ANDA203972
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-18
LATEST ACTION
2024-05-01
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
2024-05-01Labeling · Supplement 14 · standardAP
2024-05-01Labeling · Supplement 15 · standardAP
2021-03-29Labeling · Supplement 9 · standardAP
2021-03-29Labeling · Supplement 3 · standardAP
2014-08-18UNKNOWN · 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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