APPLICATION
ANDA090671
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-17
LATEST ACTION
2025-05-09
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NICARDIPINE HYDROCHLORIDEPrescription
NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) · INJECTABLE · INJECTION
Approval history
2025-05-09Labeling · Supplement 3 · standardAP
2023-02-06Manufacturing (CMC) · Supplement 2 · unknownAP
2009-11-17OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.