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As of Nov 13, 2026, ANDA 40282 (Digoxin), held by Rising, was first approved by FDA on Dec 23, 1999, with 11 approved supplements and 0 published complete response letters.
First approved: Dec 23, 1999
Supplements approved: 11
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 12 submissions below
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
