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.
As of Nov 14, 2026, ANDA 20167 (Estradiol), held by Mylan Pharms Inc, was first approved by FDA on Dec 19, 2014, with 0 approved supplements and 0 published complete response letters.
First approved: Dec 19, 2014
Supplements approved: 0
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first
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