APPLICATION
ANDA090892
TYPE
ANDA
ORIGINAL APPROVAL
2014-03-20
LATEST ACTION
2022-11-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
NIACINPrescription
NIACIN 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-11-23Labeling · Supplement 9 · standardAP
2022-11-23Labeling · Supplement 12 · standardAP
2015-10-09Manufacturing (CMC) · Supplement 3AP
2015-07-07Labeling · Supplement 4 · standardAP
2014-03-20OriginalAP
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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