Treats clinically typical, visible, or palpable actinic keratoses (AK) of the face or…. NDA 22483, held by Bausch. Imiquimod.
As of Nov 15, 2026, NDA 22483 (Zyclara), held by Bausch, was first approved by FDA on Mar 25, 2010, with 6 approved supplements and 0 published complete response letters.
| Jul 15, 2011 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Mar 24, 2011 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Mar 25, 2010 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Sep 16, 2024 | Supplement 11Labeling · Standard review | Approved | |
| Nov 24, 2014 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 14, 2012 | Supplement 6Manufacturing · Standard review | Approved | |
| Sep 29, 2011 | Supplement 2Labeling | Approved | |
| Jul 15, 2011 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Mar 24, 2011 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Mar 25, 2010 | Original applicationNew formulation or manufacturer · 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
