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As of Nov 15, 2026, NDA 21589 (Kemstro), held by Ucb Inc, was first approved by FDA on Oct 30, 2003, with 0 approved supplements and 0 published complete response letters.
First approved: Oct 30, 2003
Review: Standard
Supplements approved: 0
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first
Date
Submission
Status
Documents
Oct 30, 2003
Original applicationNew dosage form · Standard review
Kemstro10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral
Kemstro20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral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
