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FDA ANDA · ANDA206223

REMIFENTANIL HYDROCHLORIDE

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA206223
TYPE
ANDA
ORIGINAL APPROVAL
2018-01-16
LATEST ACTION
2026-06-30
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

REMIFENTANIL HYDROCHLORIDEPrescription
REMIFENTANIL HYDROCHLORIDE EQ 5MG BASE/VIAL · INJECTABLE · INJECTION
REMIFENTANIL HYDROCHLORIDEPrescription
REMIFENTANIL HYDROCHLORIDE EQ 1MG BASE/VIAL · INJECTABLE · INJECTION
REMIFENTANIL HYDROCHLORIDEPrescription
REMIFENTANIL HYDROCHLORIDE EQ 2MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2026-06-30Labeling · Supplement 6 · standardAP
2026-06-30Labeling · Supplement 10 · standardAP
2023-06-15Labeling · Supplement 2 · standardAP
2023-06-15Labeling · Supplement 1 · standardAP
2018-01-16UNKNOWN · Original · standard — Letter ↗AP
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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