Doxylamine Succinate

Sold as Decapryn, Unisom. Every FDA application for this active ingredient: 3 branded and 5 generic.

As of Nov 15, 2026, FDA lists 8 applications for Doxylamine Succinate (sold as Decapryn, Unisom), first approved Apr 7, 1948, with 0 new uses approved and 0 published complete response letters.

First approved: Apr 7, 1948
Applications: 8
New uses approved: 0
Complete response letters: 0

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Date Fruit Benefits to Treat Morning Sickness in First Trimester of PregnancyPregnancy · Bahria University	Not applicable	Active, not recruiting	Jan 21, 2026
Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in PregnancyNausea Gravidarum, Hyperemesis Gravidarum · Nawaz Sharif Medical College	Not applicable	Not yet recruiting	Jan 14, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 7, 1948	DecaprynNDA 6412 · New molecular entity	Sanofi Aventis US	0	Discontinued
Oct 18, 1978	UnisomNDA 18066 · New formulation or manufacturer	Chattem	16	Marketed
Oct 8, 1985	Doxylamine SuccinateANDA 88900	Copley Pharm	20	Discontinued
Sep 18, 1996	Doxylamine SuccinateANDA 40167	Perrigo	13	Marketed
Aug 27, 2004	Doxylamine SuccinateANDA 40564	Lnk	0	Marketed
—	Doxy-Sleep-AidANDA 70156	Par Pharm	0	Discontinued
—	Doxylamine SuccinateANDA 88603	Quantum Pharmics	0	Discontinued
—	UnisomNDA 19440	Pfizer	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA