For obesity. NDA 20766, held by Cheplapharm. Orlistat.
As of Nov 13, 2026, NDA 20766 (Xenical), held by Cheplapharm, was first approved by FDA on Apr 23, 1999, with 29 approved supplements and 0 published complete response letters.
XENICAL is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: adults and pediatric patients aged 12 years and older with obesity. adults with overweight in the presence of at least one weight-related comorbid condition.
| Oct 22, 2004 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Dec 12, 2003 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Apr 23, 1999 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xenical120MG · capsule;oral | Orlistat | RxReference drug |
| Sep 30, 2026 | Supplement 39Labeling · Standard review | Approved | |
| Nov 17, 2022 | Supplement 38Labeling · Standard review | Approved | |
| Aug 12, 2016 | Supplement 36Labeling · Standard review | Approved | |
| Aug 7, 2015 | Supplement 35Labeling · Standard review | Approved | |
| Apr 30, 2014 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Oct 16, 2013 | Supplement 33Labeling · Standard review | Approved | |
| Apr 5, 2013 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Apr 2, 2013 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Jan 20, 2012 | Supplement 29Labeling | Approved | |
| Dec 17, 2010 | Supplement 30Manufacturing · Priority review | Approved | |
| May 25, 2010 | Supplement 28Labeling | Approved | |
| Feb 11, 2009 | Supplement 26Labeling · Standard review | Approved | |
| Jan 5, 2007 | Supplement 22Labeling · Standard review | Approved | |
| Sep 2, 2005 | Supplement 21Labeling · Standard review | Approved | |
| Oct 22, 2004 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Jul 9, 2004 | Supplement 20Labeling · Standard review | Approved | |
| Dec 12, 2003 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Mar 8, 2002 | Supplement 13Manufacturing · Priority review | Approved | |
| Feb 27, 2002 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Feb 21, 2002 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Dec 19, 2001 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Dec 19, 2001 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Nov 12, 2001 | Supplement 9Manufacturing · Priority review | Approved | |
| Jun 25, 2001 | Supplement 7Labeling · Standard review | Approved | |
| Jan 29, 2001 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jan 9, 2001 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Apr 6, 2000 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 6, 2000 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 31, 1999 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 23, 1999 | Original applicationNew molecular entity · Priority 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
