APPLICATION
ANDA208532
TYPE
ANDA
ORIGINAL APPROVAL
2018-08-21
LATEST ACTION
2024-11-06
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXMEDETOMIDINE HYDROCHLORIDEPrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · INJECTABLE · INJECTION
DEXMEDETOMIDINE HYDROCHLORIDEPrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · INJECTABLE · INJECTION
Approval history
2024-11-06Labeling · Supplement 6 · standardAP
2024-11-06Labeling · Supplement 5 · standardAP
2020-08-14Labeling · Supplement 4 · standardAP
2020-08-14Labeling · Supplement 2 · 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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