NDA 22501, held by Apil. Ethinyl Estradiol; Norethindrone Acetate.
As of Nov 14, 2026, NDA 22501 (Lo Loestrin Fe), held by Apil, was first approved by FDA on Oct 21, 2010, with 6 approved supplements and 0 published complete response letters.
Lo Loestrin Fe is indicated for use by women to prevent pregnancy. The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated. Lo Loestrin Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy The efficacy of Lo Loestrin Fe in women with a body mass index of > 35 kg/m 2 has not been evaluated ( 1, 8.8 )
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2010 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lo Loestrin Fe0.01MG,0.01MG;1MG,N/A · tablet;oral | Ethinyl Estradiol; Norethindrone Acetate | RxReference drug |
| Apr 29, 2022 | Supplement 15Labeling · Standard review | Approved | |
| Oct 15, 2021 | Supplement 12Labeling · Standard review | Approved | |
| Oct 10, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 8Labeling · Standard review | Approved | |
| May 8, 2013 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 1, 2013 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Oct 21, 2010 | Original applicationNew dosage form · 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
