ANDA 213418, held by Glenmark Pharms Ltd. Ethinyl Estradiol; Norethindrone Acetate.
As of Nov 15, 2026, ANDA 213418 (Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate), held by Glenmark Pharms Ltd, was first approved by FDA on Jul 27, 2022, with 1 approved supplement and 0 published complete response letters.
Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are indicated for use by females of reproductive age to prevent pregnancy. The efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 27, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate0.02MG;1MG · capsule;oral | Ethinyl Estradiol; Norethindrone Acetate | Rx |
| Jan 9, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 27, 2022 | 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
