Diclegis

Treats nausea and vomiting of pregnancy. NDA 21876, held by Duchesnay. Doxylamine Succinate; Pyridoxine Hydrochloride.

As of Nov 14, 2026, NDA 21876 (Diclegis), held by Duchesnay, was first approved by FDA on Apr 8, 2013, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 8, 2013
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets have not been studied in women with hyperemesis gravidarum.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 8, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diclegis10MG;10MG · tablet, delayed release;oral	Doxylamine Succinate; Pyridoxine Hydrochloride	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Oct 31, 2022	Supplement 16Labeling · Standard review	Approved	Letter Label
Jun 18, 2018	Supplement 13Labeling · Standard review	Approved	Letter Label
Mar 10, 2016	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 10, 2015	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 23, 2015	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 16, 2014	Supplement 6Labeling · Standard review	Approved	Letter
Nov 24, 2014	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 30, 2014	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 28, 2014	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 29, 2014	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 30, 2013	Supplement 2Manufacturing · Standard review	Approved	Label
Apr 8, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 21876
Drugs@FDA: Overview at FDA
Company: Duchesnay

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