ANDA 78833, held by Watson Labs. Drospirenone; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 78833 (Drospirenone And Ethinyl Estradiol), held by Watson Labs, was first approved by FDA on Nov 28, 2011, with 4 approved supplements and 0 published complete response letters.
Vestura 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 |
|---|---|---|---|
| Nov 28, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Drospirenone And Ethinyl Estradiol3MG;0.02MG · tablet;oral | Drospirenone; Ethinyl Estradiol | Rx |
| Oct 24, 2023 | Supplement 22Labeling · Standard review | Approved | None posted |
| Oct 24, 2023 | Supplement 24Labeling · Standard review | Approved | None posted |
| Apr 30, 2020 | Supplement 14Labeling · Standard review | Approved | None posted |
| Apr 2, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 28, 2011 | 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
