APPLICATION
ANDA076378
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-26
LATEST ACTION
2015-07-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
NIACINPrescription
NIACIN 500MG · TABLET, EXTENDED RELEASE · ORAL
NIACINPrescription
NIACIN 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2015-07-07Labeling · Supplement 13 · standardAP
2013-09-11Manufacturing (CMC) · Supplement 11 · unknownAP
2007-12-20Labeling · Supplement 5AP
2007-09-19Labeling · Supplement 4AP
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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