Cervidil

NDA 20411, held by Ferring Pharms Inc. Dinoprostone.

As of Nov 14, 2026, NDA 20411 (Cervidil), held by Ferring Pharms Inc, was first approved by FDA on Mar 30, 1995, with 21 approved supplements and 0 published complete response letters.

First approved: Mar 30, 1995
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Mar 30, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cervidil10MG · insert, extended release;vaginal	Dinoprostone	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


Jul 7, 2020	Supplement 31Labeling · Standard review	Approved	Letter Label
May 26, 2010	Supplement 27Labeling · Standard review	Approved	Letter Label
Nov 28, 2006	Supplement 23Labeling · Standard review	Approved	Letter Label
Jan 25, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 21, 2001	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 6, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 30, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 27, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 13, 2000	Supplement 16Labeling · Standard review	Approved	None posted
Feb 11, 2000	Supplement 14Labeling · Standard review	Approved	None posted
Nov 5, 1999	Supplement 11Labeling · Standard review	Approved	None posted
Aug 31, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 24, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 19, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 24, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 3, 1998	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 24, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 18, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 4, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 22, 1996	Supplement 1Labeling · Standard review	Approved	None posted
Aug 29, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 30, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20411
Drugs@FDA: Overview at FDA
Company: Ferring Pharmaceuticals

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