Dextromethorphan Hydrobromide; Quinidine Sulfate

Treats pseudobulbar affect (PBA). Sold as Nuedexta. Every FDA application for this active ingredient: 1 branded and 4 generic.

As of Nov 15, 2026, FDA lists 5 applications for Dextromethorphan Hydrobromide; Quinidine Sulfate (sold as Nuedexta), first approved Oct 29, 2010, with 0 new uses approved and 0 published complete response letters.

First approved: Oct 29, 2010
Applications: 5
New uses approved: 0
Complete response letters: 0
First approved in the EU: Jun 24, 2013

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

NUEDEXTA 20-10 MG CAPSULE: $26.58 per unitBrand · +3% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of amyotrophic lateral sclerosis (ALS)Avanir Pharmaceuticals · designated Feb 14, 2017

Approvals in the EU (EMA)

First approved in the EU 32 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Nuedexta, new substanceJenson Pharmaceutical Services Limited · Jun 24, 2013 · withdrawn

Applications

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


Oct 29, 2010	NuedextaNDA 21879 · New combination	Otsuka America Pharm	7	Marketed
Oct 10, 2017	Dextromethorphan Hydrobromide And Quinidine SulfateANDA 202934	Actavis Elizabeth	2	Marketed
Aug 28, 2024	Dextromethorphan Hydrobromide And Quinidine SulfateANDA 218426	Hetero Labs Ltd Iii	0	Marketed
Jun 3, 2026	Dextromethorphan Hydrobromide And Quinidine SulfateANDA 204196	Sun Pharm	0	Marketed
—	Dextromethorphan Hydrobromide And Quinidine SulfateANDA 202993	Par Pharm Inc	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