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As of Nov 14, 2026, NDA 21546 (Rebetol), held by Schering, was first approved by FDA on Jul 29, 2003, with 11 approved supplements and 0 published complete response letters.
First approved: Jul 29, 2003
Review: Priority
Supplements approved: 11
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 12 submissions below
Date
Submission
Status
Documents
Jul 29, 2003
Original applicationNew dosage form · Priority review
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
