NDA 21887, held by Haleon US Holdings. Orlistat.
As of Nov 14, 2026, NDA 21887 (Alli), held by Haleon US Holdings, was first approved by FDA on Feb 7, 2007, with 7 approved supplements and 0 published complete response letters.
Use for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2007 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alli60MG · capsule;oral | Orlistat | OTCReference drug |
| Mar 27, 2026 | Supplement 13Labeling · Standard review | Approved | |
| May 15, 2017 | Supplement 9Labeling · Standard review | Approved | |
| May 25, 2016 | Supplement 8Labeling · Standard review | Approved | |
| Jun 13, 2014 | Supplement 6Labeling · Standard review | Approved | |
| Mar 10, 2011 | Supplement 5Labeling | Approved | |
| Feb 4, 2011 | Supplement 4Labeling · Standard review | Approved | |
| Sep 22, 2010 | Supplement 2Labeling | Approved | |
| Feb 7, 2007 | 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
