Orange Book product · Brand (NDA)

ZOLPIMIST

ZOLPIDEM TARTRATE

Brand (NDA)NDA 022196DISCN AYTU

Dec 19, 2008

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 19, 2008
17 yr 9 mo ago
Today
Patent 8236285 expires
Listed drug substance patent expiration.
Aug 07, 2032
in 6 yr 3 mo

Active ingredient

ZOLPIDEM TARTRATE

Strength

5MG/SPRAY

Dosage form

SPRAY, METERED

Route

ORAL

TE code

Not listed

Application

NDA 022196

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
8236285	Aug 07, 2032	in 6 yr 3 mo	SubstanceProductU-70