APPLICATION
ANDA090365
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-17
LATEST ACTION
2015-11-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
FELODIPINEPrescription
FELODIPINE 10MG · TABLET, EXTENDED RELEASE · ORAL
FELODIPINEPrescription
FELODIPINE 2.5MG · TABLET, EXTENDED RELEASE · ORAL
FELODIPINEPrescription
FELODIPINE 5MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2015-11-30Labeling · Supplement 3 · standardAP
2010-12-17OriginalAP
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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