APPLICATION
ANDA204934
TYPE
ANDA
ORIGINAL APPROVAL
2022-03-03
LATEST ACTION
2025-04-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
NIACINPrescription
NIACIN 1GM · TABLET, EXTENDED RELEASE · ORAL
NIACINPrescription
NIACIN 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-04-10Labeling · Supplement 3 · standardAP
2023-06-07Labeling · Supplement 2 · standardAP
2022-03-03UNKNOWN · 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.