NDA 50742, held by Merck Sharp Dohme. Ivermectin.
As of Nov 13, 2026, NDA 50742 (Stromectol), held by Merck Sharp Dohme, was first approved by FDA on Nov 22, 1996, with 25 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE STROMECTOL is indicated for the treatment of the following infections: Strongyloidiasis of the intestinal tract. STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.) Onchocerciasis. STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 1996 | Original applicationNew molecular entity · Priority review | Approved |
| Stromectol6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ivermectin | DiscontinuedReference drug |
| Stromectol3MG · tablet;oral | Ivermectin | RxReference drug |
| Mar 14, 2022 | Supplement 30Labeling · Standard review | Approved | |
| May 11, 2015 | Supplement 28Manufacturing | Approved | None posted |
| Apr 7, 2015 | Supplement 27Manufacturing | Approved | None posted |
| Dec 15, 2009 | Supplement 26Labeling · Standard review | Approved | |
| Jun 11, 2009 | Supplement 25Labeling · Standard review | Approved | |
| Jun 11, 2009 | Supplement 24Labeling · Standard review | Approved | |
| May 1, 2009 | Supplement 23Labeling · Standard review | Approved | |
| Sep 12, 2008 | Supplement 22Labeling · Standard review | Approved | |
| Feb 26, 2008 | Supplement 20Manufacturing | Approved | |
| Sep 26, 2007 | Supplement 21Labeling · Standard review | Approved | |
| Sep 26, 2007 | Supplement 19Labeling · Standard review | Approved | |
| Jan 20, 2006 | Supplement 18Labeling · Standard review | Approved | |
| Jan 20, 2006 | Supplement 17Labeling · Standard review | Approved | |
| Nov 18, 2004 | Supplement 15Labeling · Standard review | Approved | |
| Feb 12, 2004 | Supplement 13Labeling · Standard review | Approved | |
| Feb 12, 2004 | Supplement 12Labeling · Standard review | Approved | |
| Jan 15, 2003 | Supplement 11Labeling · Standard review | Approved | |
| Dec 12, 2002 | Supplement 8Manufacturing | Approved | None posted |
| May 28, 2002 | Supplement 7Manufacturing | Approved | None posted |
| Jul 17, 2001 | Supplement 6Manufacturing | Approved | None posted |
| Jan 4, 2001 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jan 4, 2001 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 10, 1999 | Supplement 4Manufacturing | Approved | None posted |
| Aug 4, 1999 | Supplement 3Manufacturing | Approved | None posted |
| Oct 8, 1998 | Supplement 1Manufacturing | Approved | |
| Nov 22, 1996 | 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
