NDA 22001, held by Novo Nordisk Inc. Estradiol; Norethindrone Acetate.
As of Nov 14, 2026, NDA 22001 (Activella), held by Novo Nordisk Inc, was first approved by FDA on Dec 29, 2006, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 2006 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Activella1MG/0.5MG · tablet; oral | 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
