Orange Book product · Brand (NDA)

INTERMEZZO

ZOLPIDEM TARTRATE

Brand (NDA)NDA 022328DISCN PURDUE PHARMA

Nov 23, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 23, 2011
14 yr 9 mo ago
Today
Patent 7658945 expires
Listed drug product patent expiration.
Apr 15, 2027
in 10 mo
Patent 8242131 expires
Listed method-of-use patent (U-1266) expiration.
Aug 20, 2029
in 3 yr 3 mo

Active ingredient

ZOLPIDEM TARTRATE

Strength

1.75MG

Dosage form

TABLET

Route

SUBLINGUAL

TE code

Not listed

Application

NDA 022328

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
7658945	Apr 15, 2027	in 10 mo	ProductU-1194
8242131	Aug 20, 2029	in 3 yr 3 mo	U-1266