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Treats non-esophageal mucus membrane gastrointestinal candidiasis. ANDA 62474, held by Heritage. Nystatin.
As of Nov 14, 2026, ANDA 62474 (Nystatin), held by Heritage, was first approved by FDA on Dec 22, 1983, with 5 approved supplements and 0 published complete response letters.
First approved: Dec 22, 1983
Supplements approved: 5
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
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
