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FDA ANDA · ANDA212857
DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE
dexmedetomidine hydrochloride
Sponsor: TAGI
APPLICATION
ANDA212857
TYPE
ANDA
ORIGINAL APPROVAL
2020-11-23
LATEST ACTION
2026-02-17
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
DEXMEDETOMIDINE HYDROCHLORIDEPrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) · INJECTABLE · INJECTION
Approval history
2026-02-17Labeling · Supplement 3 · standardAP
2020-11-23UNKNOWN · 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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