APPLICATION
ANDA215406
TYPE
ANDA
ORIGINAL APPROVAL
2024-10-31
LATEST ACTION
2026-03-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NICARDIPINE HYDROCHLORIDEDiscontinued
NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) · INJECTABLE · INJECTION
Approval history
2026-03-06Labeling · Supplement 1 · standardAP
2024-10-31UNKNOWN · 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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