Treats Moderate. NDA 21258, held by Bayer Hlthcare. Estradiol; Levonorgestrel.
As of Nov 14, 2026, NDA 21258 (Climara Pro), held by Bayer Hlthcare, was first approved by FDA on Nov 21, 2003, with 7 approved supplements and 0 published complete response letters.
Climara Pro is indicated for: Climara Pro is an estrogen plus progestin indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Prevention of Postmenopausal Osteoporosis Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 21, 2003 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Climara Pro0.045MG/24HR;0.015MG/24HR · film, extended release;transdermal | Estradiol; Levonorgestrel | RxReference drug |
| Feb 15, 2024 | Supplement 15Labeling · Standard review | Approved | |
| Nov 15, 2021 | Supplement 12Labeling · Standard review | Approved | |
| Oct 7, 2021 | Supplement 13Labeling · Standard review | Approved | |
| Nov 1, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Mar 8, 2016 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Oct 9, 2013 | Supplement 6Labeling · Standard review | Approved | |
| Jun 22, 2005 | Supplement 3Labeling · Standard review | Approved | |
| Nov 21, 2003 | Original applicationNew combination · Standard review | Approved |
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
