NDA 21998, held by Fdn Consumer. Levonorgestrel.
As of Nov 13, 2026, NDA 21998 (Plan B One-Step), held by Fdn Consumer, was first approved by FDA on Jul 10, 2009, with 5 approved supplements and 0 published complete response letters.
Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
| Jun 20, 2013 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Apr 30, 2013 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jul 10, 2009 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Plan B One-Step1.5MG · tablet;oral | Levonorgestrel | OTCReference drug |
| Dec 23, 2022 | Supplement 5Labeling · Standard review | Approved | |
| Jan 4, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Aug 10, 2017 | Supplement 4Labeling · Standard review | Approved | |
| Jun 20, 2013 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Apr 30, 2013 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jul 10, 2009 | Original applicationNew dosage form · Standard review | Approved |
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
