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As of Nov 14, 2026, NDA 211210 (Qmiiz Odt), held by Tersera, was first approved by FDA on Oct 19, 2018, with 2 approved supplements and 0 published complete response letters.
First approved: Oct 19, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 3 submissions below
Date
Submission
Status
Documents
Oct 19, 2018
Original applicationNew dosage form · Standard review
Qmiiz Odt7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral
Qmiiz Odt15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral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
