NDA 204426, held by Apil. Ethinyl Estradiol; Norethindrone Acetate.
As of Nov 14, 2026, NDA 204426 (Taytulla), held by Apil, was first approved by FDA on Apr 19, 2013, with 5 approved supplements and 0 published complete response letters.
1 INDICATION S AND USAGE TAYTULLA is indicated for use by females of reproductive age to prevent pregnancy. The efficacy of TAYTULLA in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. TAYTULLA 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 of TAYTULLA in females of reproductive potential with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated ( 1, 8.8 )
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 19, 2013 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Taytulla0.02MG;1MG · capsule;oral | Ethinyl Estradiol; Norethindrone Acetate | RxReference drug |
| Jun 26, 2023 | Supplement 9Labeling · Standard review | Approved | |
| Apr 29, 2022 | Supplement 10Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 7Labeling · Standard review | Approved | |
| Aug 19, 2016 | Supplement 4Labeling · Standard review | Approved | |
| Jul 22, 2015 | Supplement 1Manufacturing · Standard review | Approved | |
| Apr 19, 2013 | 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
