Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats candidiasis in the oral cavity. ANDA 65148, held by Genus. Nystatin.
As of Nov 14, 2026, ANDA 65148 (Nystatin), held by Genus, was first approved by FDA on Jun 28, 2005, with 1 approved supplement and 0 published complete response letters.
First approved: Jun 28, 2005
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
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
