NDA 21885, held by Berlex Labs. Estradiol; Levonorgestrel.
As of Nov 14, 2026, NDA 21885 (Climara Pro), held by Berlex Labs, was first approved by FDA on Dec 27, 2005, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 2005 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Climara Pro0.045MG · system; transdermal | Estradiol; Levonorgestrel | 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
