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FDA ANDA · ANDA208129

DEXMEDETOMIDINE HYDROCHLORIDE

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA208129
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-29
LATEST ACTION
2024-05-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
None (Tentative Approval), Prescription

Products

DEXMEDETOMIDINE HYDROCHLORIDENone (Tentative Approval)
DEXMEDETOMIDINE HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) · INJECTABLE · INJECTION
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

2024-05-28Labeling · Supplement 5 · standardAP
2018-11-29UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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