ANDA 207033, held by Naari Pte. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 207033 (Levonorgestrel And Ethinyl Estradiol), held by Naari Pte, was first approved by FDA on Oct 9, 2020, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levonorgestrel And Ethinyl Estradiol0.03MG;0.15MG · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | Rx |
| Apr 29, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 9, 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
