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As of Nov 13, 2026, NDA 20381 (Niaspan, Niaspan Titration Starter Pack), held by Abbvie, was first approved by FDA on Jul 28, 1997, with 31 approved supplements and 0 published complete response letters.
First approved: Jul 28, 1997
Review: Standard
Supplements approved: 31
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 32 submissions below
Date
Submission
Status
Documents
Jan 31, 2003
Supplement 13Efficacy (new indication or use) · Standard review
Niaspan500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral
Niaspan750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral
Niaspan1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
