ANDA 210087, held by Teva Pharms USA Inc. Ethinyl Estradiol; Norethindrone Acetate.
As of Nov 15, 2026, ANDA 210087 (Finzala), held by Teva Pharms USA Inc, was first approved by FDA on Apr 7, 2020, with 2 approved supplements and 0 published complete response letters.
Finzala is indicated for use by females of reproductive age to prevent pregnancy. The efficacy of Finzala in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. Finzala is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy The efficacy in females of reproductive potential with a body mass index of more than 35 kg/m 2 has not been evaluated ( 1, 8.8 )
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 7, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Finzala0.02MG;1MG · tablet;oral | Ethinyl Estradiol; Norethindrone Acetate | Rx |
| Feb 27, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jun 21, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 7, 2020 | Original application | Approved | None posted |
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
