ANDA 209632, held by Aurobindo Pharma Ltd. Drospirenone; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 209632 (Lo-Zumandimine), held by Aurobindo Pharma Ltd, was first approved by FDA on Feb 27, 2018, with 2 approved supplements and 0 published complete response letters.
Jasmiel 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 |
|---|---|---|---|
| Feb 27, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lo-Zumandimine3MG;0.02MG · tablet;oral | Drospirenone; Ethinyl Estradiol | Rx |
| Aug 16, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 16, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 27, 2018 | 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
