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FDA ANDA · ANDA210321

DEXMEDETOMIDINE HYDROCHLORIDE

dexmedetomidine hydrochloride in 0.9% sodium chloride

Sponsor: EUGIA PHARMA

APPLICATION
ANDA210321
TYPE
ANDA
ORIGINAL APPROVAL
2020-12-07
LATEST ACTION
2023-07-03
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

2023-07-03Labeling · Supplement 6 · standardAP
2020-12-07UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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