NDA 21310, held by Watson Labs. Estradiol.
As of Nov 15, 2026, NDA 21310 (Alora), held by Watson Labs, was first approved by FDA on Apr 5, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 5, 2002 | Original applicationNew indication · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AloraN/A · film, extended release; transdermal | Estradiol | Rx |
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