APPLICATION
ANDA090664
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-17
LATEST ACTION
2020-05-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NICARDIPINE HYDROCHLORIDEPrescription
NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) · INJECTABLE · INJECTION
Approval history
2020-05-27Labeling · Supplement 4 · standardAP
2020-05-27Labeling · Supplement 5 · standardAP
2011-12-31Labeling · Supplement 2AP
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.
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