APPLICATION
ANDA200484
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-23
LATEST ACTION
2023-02-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
NIACINPrescription
NIACIN 500MG · TABLET, EXTENDED RELEASE · ORAL
NIACINPrescription
NIACIN 1GM · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-02-02Labeling · Supplement 11 · standardAP
2023-02-02Labeling · Supplement 8 · standardAP
2015-07-09Labeling · Supplement 1 · standardAP
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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