APPLICATION
ANDA202644
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-25
LATEST ACTION
2016-01-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NIFEDIPINEPrescription
NIFEDIPINE 20MG · CAPSULE · ORAL
NIFEDIPINEPrescription
NIFEDIPINE 10MG · CAPSULE · ORAL
Approval history
2016-01-26Labeling · Supplement 4 · standardAP
2014-12-11Labeling · Supplement 1 · standardAP
2014-12-11Labeling · Supplement 2 · standardAP
2013-04-25UNKNOWN · OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.