ANDA 209547, held by Novast Labs. Ethinyl Estradiol; Ethynodiol Diacetate.
As of Nov 15, 2026, ANDA 209547 (Malmorede), held by Novast Labs, was first approved by FDA on Jul 25, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Malmorede0.05MG;1MG ยท tablet;oral-28 | Ethinyl Estradiol; Ethynodiol Diacetate | 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
