NDA 16749, held by Parke Davis. Ethinyl Estradiol; Norethindrone Acetate.
As of Nov 13, 2026, NDA 16749 (Norlestrin 21 1/50), held by Parke Davis, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Norlestrin 21 1/500.05MG;1MG ยท tablet;oral-21 | Ethinyl Estradiol; Norethindrone Acetate | 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