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FDA ANDA · ANDA210594

REMIFENTANIL HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
ANDA210594
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-13
LATEST ACTION
2024-06-18
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

2024-06-18Labeling · Supplement 3 · standardAP
2020-10-13UNKNOWN · 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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