ANDA 201661, held by Lupin. Drospirenone; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 201661 (Nikki), held by Lupin, was first approved by FDA on May 27, 2014, with 7 approved supplements and 0 published complete response letters.
Nikki (drospirenone and ethinyl estradiol tablets USP) is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: Prevent pregnancy. Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. 1.1 Oral Contraceptive
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 27, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nikki3MG;0.02MG · tablet;oral | Drospirenone; Ethinyl Estradiol | Rx |
| Oct 24, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 24, 2023 | Supplement 17Labeling · Standard review | Approved | None posted |
| Oct 24, 2023 | Supplement 18Labeling · Standard review | Approved | None posted |
| Apr 3, 2020 | Supplement 10Manufacturing | Approved | None posted |
| Mar 11, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 11, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 11, 2019 | Supplement 6Manufacturing | Approved | None posted |
| May 27, 2014 | 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
