NDA 21102, held by Warner Chilcott. Ethinyl Estradiol; Norethindrone Acetate.
As of Nov 13, 2026, NDA 21102 (Femhrt), held by Warner Chilcott, was first approved by FDA on Oct 15, 1999, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 1999 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Femhrt0.005MG;1MG · tablet; oral | Ethinyl Estradiol; Norethindrone Acetate | 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
