Treats Moderate. NDA 20907, held by Amneal. Estradiol; Norethindrone Acetate.
As of Nov 13, 2026, NDA 20907 (Activella), held by Amneal, was first approved by FDA on Nov 18, 1998, with 17 approved supplements and 0 published complete response letters.
Lopreeza is indicated for: Lopreeza is an estrogen and progestin combination indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitations of Use: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. Prevention of Postmenopausal Osteoporosis Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications.
| Dec 28, 2006 | Supplement 9Efficacy (new indication or use) | Approved | |
| Nov 18, 1998 | Original applicationNew combination · Standard review | Approved |
| Activella1MG;0.5MG · tablet;oral | Estradiol; Norethindrone Acetate | RxReference drug |
| Activella0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Estradiol; Norethindrone Acetate | DiscontinuedReference drug |
| Feb 15, 2024 | Supplement 30Labeling · Standard review | Approved | |
| Aug 10, 2021 | Supplement 20Labeling · Standard review | Approved | |
| Aug 10, 2021 | Supplement 22Labeling · Standard review | Approved | |
| Apr 6, 2020 | Supplement 25Manufacturing | Approved | |
| Nov 1, 2017 | Supplement 19Labeling · Standard review | Approved | |
| May 27, 2016 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jan 12, 2015 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Oct 8, 2013 | Supplement 13Labeling · Standard review | Approved | |
| Dec 28, 2006 | Supplement 11Labeling · Standard review | Approved | |
| Dec 28, 2006 | Supplement 9Efficacy (new indication or use) | Approved | |
| Jun 30, 2005 | Supplement 5Labeling · Standard review | Approved | |
| Jul 26, 2004 | Supplement 7 | Approved | |
| Sep 13, 2002 | Supplement 6Manufacturing · Standard review | Approved | |
| Nov 14, 2000 | Supplement 4Manufacturing · Standard review | Approved | |
| Apr 11, 2000 | Supplement 3Labeling · Standard review | Approved | |
| Feb 10, 2000 | Supplement 2Labeling · Standard review | Approved | |
| Nov 3, 1999 | Supplement 1Manufacturing · Standard review | Approved | |
| Nov 18, 1998 | 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
