ANDA 83518, held by Sanofi Aventis US. Dienestrol.
As of Nov 15, 2026, ANDA 83518 (Dv), held by Sanofi Aventis US, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Dv0.01% ยท cream;vaginal | Dienestrol | Discontinued |
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