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FDA ANDA · ANDA209307

DEXMEDETOMIDINE HYDROCHLORIDE

Sponsor: GLAND

APPLICATION
ANDA209307
TYPE
ANDA
ORIGINAL APPROVAL
2020-06-03
LATEST ACTION
2024-12-19
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DEXMEDETOMIDINE HYDROCHLORIDEPrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · INJECTABLE · INJECTION
DEXMEDETOMIDINE HYDROCHLORIDEPrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · INJECTABLE · INJECTION

Approval history

2024-12-19Manufacturing (CMC) · Supplement 5 · unknownAP
2020-06-03UNKNOWN · Original · standardAP
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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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