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FDA ANDA · ANDA215635

REMIFENTANIL HYDROCHLORIDE

Sponsor: NIVAGEN PHARMS INC

APPLICATION
ANDA215635
TYPE
ANDA
ORIGINAL APPROVAL
2024-06-28
LATEST ACTION
2024-06-28
ROUTE
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

2024-06-28UNKNOWN · 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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