INDICATIONS AND USAGE IMPORTANT NOTICE Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor. Antepartum: Pitocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 1980 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 11, 2021 | Supplement 41Labeling · Standard review | Approved | |
| Aug 15, 2016 | Supplement 33Manufacturing | Approved | None posted |
| Oct 2, 2014 | Supplement 31Labeling · Standard review | Approved | |
| Jun 18, 2014 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Jul 27, 2007 | Supplement 28Manufacturing | Approved | |
| Mar 24, 2003 | Supplement 23Labeling · Standard review | Approved | |
| Jan 10, 2002 | Supplement 21Labeling · Standard review | Approved | |
| Sep 24, 2001 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Mar 8, 2001 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Mar 8, 2001 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Mar 8, 2001 | Supplement 20Labeling · Standard review | Approved | None posted |
| Oct 25, 2000 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Mar 23, 2000 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Mar 1, 2000 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Nov 10, 1999 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1999 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jul 29, 1997 | Supplement 11Labeling · Standard review | Approved | |
| Jul 10, 1997 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1996 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 23, 1994 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 9, 1994 | Supplement 6Labeling | Approved | None posted |
| May 27, 1994 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 3, 1990 | Supplement 5Labeling | Approved | None posted |
| Feb 16, 1988 | Supplement 4Labeling | Approved | None posted |
| Jan 29, 1987 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 19, 1986 | Supplement 2Labeling | Approved | None posted |
| Jan 27, 1984 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Nov 19, 1980 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
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
