APPLICATION
ANDA209236
TYPE
ANDA
ORIGINAL APPROVAL
2018-02-01
LATEST ACTION
2022-11-29
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
NIACINPrescription
NIACIN 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-11-29Labeling · Supplement 5 · standardAP
2022-11-29Labeling · Supplement 3 · standardAP
2018-02-01UNKNOWN · Original · 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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