ANDA 207976, held by Novast Labs. Levonorgestrel.
As of Nov 13, 2026, ANDA 207976 (Her Style), held by Novast Labs, was first approved by FDA on Mar 11, 2016, with 3 approved supplements and 0 published complete response letters.
USE Use for women to reduce the chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 11, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Her Style1.5MG · tablet;oral | Levonorgestrel | OTC |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 16, 2017 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 16, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 11, 2016 | 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
