APPLICATION
ANDA074928
TYPE
ANDA
ORIGINAL APPROVAL
1998-03-19
LATEST ACTION
2025-04-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NICARDIPINE HYDROCHLORIDEPrescription
NICARDIPINE HYDROCHLORIDE 20MG · CAPSULE · ORAL
NICARDIPINE HYDROCHLORIDEPrescription
NICARDIPINE HYDROCHLORIDE 30MG · CAPSULE · ORAL
Approval history
2025-04-17Labeling · Supplement 8 · standardAP
2002-07-17Labeling · Supplement 5AP
1999-12-15Labeling · Supplement 4AP
1998-12-01Manufacturing (CMC) · Supplement 2AP
1998-12-01Manufacturing (CMC) · Supplement 3AP
1998-12-01Manufacturing (CMC) · Supplement 1AP
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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