APPLICATION
ANDA217548
TYPE
ANDA
ORIGINAL APPROVAL
2024-09-06
LATEST ACTION
2025-12-18
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NICARDIPINE HYDROCHLORIDEPrescription
NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) · INJECTABLE · INJECTION
Approval history
2025-12-18Manufacturing (CMC) · Supplement 1 · unknownAP
2024-09-06UNKNOWN · 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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