ANDA 202635, held by Sun Pharm. Levonorgestrel.
As of Nov 13, 2026, ANDA 202635 (Opcicon One-Step), held by Sun Pharm, was first approved by FDA on Sep 11, 2014, with 1 approved supplement and 0 published complete response letters.
Use for women to reduce chance of pregnancy af ter unprotected sex (if a contraceptive failed or if you did not use bir th control)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 11, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Opcicon One-Step1.5MG · tablet;oral | Levonorgestrel | OTC |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 11, 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
