For a medical or obstetrical need for labor induction. NDA 19617, held by Pfizer. Dinoprostone.
As of Nov 14, 2026, NDA 19617 (Prepidil), held by Pfizer, was first approved by FDA on Dec 9, 1992, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 9, 1992 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prepidil0.5MG/3GM · gel;endocervical | Dinoprostone | RxReference drug |
| Jul 5, 2017 | Supplement 17Labeling · Standard review | Approved | |
| Feb 3, 2015 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 10, 2013 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 12, 2010 | Supplement 10Labeling · Standard review | Approved | |
| Apr 26, 2002 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jun 7, 2001 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1999 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 27, 1996 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 9, 1992 | Original applicationNew dosage form · 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
