APPLICATION
ANDA220243
TYPE
ANDA
ORIGINAL APPROVAL
2025-10-22
LATEST ACTION
2025-10-22
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEPrescription
NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) · INJECTABLE · INTRAVENOUS
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEPrescription
NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2025-10-22UNKNOWN · Original · standardAP
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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