Lowers the risk of NSAID (nonsteroidal anti-inflammatory drugs, including…. NDA 19268, held by Pfizer. Misoprostol.
As of Nov 13, 2026, NDA 19268 (Cytotec), held by Pfizer, was first approved by FDA on Dec 27, 1988, with 38 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 1988 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cytotec0.2MG · tablet;oral | Misoprostol | RxReference drug |
| Cytotec0.1MG · tablet;oral | Misoprostol | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2018 | Supplement 51Labeling · Standard review | Approved | |
| Dec 19, 2016 | Supplement 49Labeling · Standard review | Approved | |
| Feb 8, 2013 | Supplement 48Manufacturing · Priority review | Approved | None posted |
| Nov 19, 2012 | Supplement 47Labeling · Standard review | Approved | |
| Sep 11, 2009 | Supplement 41Labeling · Standard review | Approved | |
| Aug 13, 2003 | Supplement 40Labeling · Standard review | Approved | |
| Aug 13, 2003 | Supplement 39Labeling · Standard review | Approved | |
| Jul 1, 2002 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Apr 17, 2002 | Supplement 37Labeling · Standard review | Approved | |
| Oct 19, 2000 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Oct 19, 2000 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Jun 22, 2000 | Supplement 31Labeling · Standard review | Approved | None posted |
| Jan 7, 2000 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Aug 11, 1999 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Dec 3, 1998 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Oct 15, 1998 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Oct 15, 1998 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Jul 14, 1998 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Aug 13, 1997 | Supplement 23Labeling · Standard review | Approved | None posted |
| Jul 30, 1997 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Apr 10, 1997 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Jun 11, 1996 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Jun 10, 1996 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| May 31, 1994 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| May 10, 1993 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Oct 28, 1992 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Jul 29, 1991 | Supplement 15Labeling | Approved | None posted |
| Jun 21, 1991 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Apr 23, 1991 | Supplement 14Labeling | Approved | None posted |
| Sep 21, 1990 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Sep 6, 1990 | Supplement 13Labeling | Approved | None posted |
| Jul 16, 1990 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| May 9, 1990 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Apr 5, 1990 | Supplement 10Labeling | Approved | None posted |
| Apr 5, 1990 | Supplement 8Labeling | Approved | None posted |
| Jun 27, 1989 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Apr 18, 1989 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Feb 8, 1989 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Dec 27, 1988 | 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
