Orange Book product · Brand (NDA)

NUEDEXTA

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

Brand (NDA)NDA 021879TE ABRX OTSUKA AMERICA PHARM

Oct 29, 2010

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 29, 2010
15 yr 10 mo ago
Today
Patent 7659282 expires
Listed method-of-use patent (U-1093) expiration.
Aug 13, 2026
in 2 mo

Active ingredient

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

Strength

20MG;10MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 021879

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7659282	Aug 13, 2026	in 2 mo	U-1093