Orange Book product · Brand (NDA)

EDLUAR

ZOLPIDEM TARTRATE

Brand (NDA)NDA 021997TE ABRX VIATRIS

Mar 13, 2009

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 13, 2009
17 yr 6 mo ago
Today
Patent 9597281 expires
Listed method-of-use patent (U-674) expiration.
Apr 06, 2027
in 10 mo
Patent 9265720 expires
Listed method-of-use patent (U-674) expiration.
Feb 25, 2031
in 4 yr 9 mo

Active ingredient

ZOLPIDEM TARTRATE

Strength

5MG

Dosage form

TABLET

Route

SUBLINGUAL

TE code

Application

NDA 021997

Product number

001

Marketing status

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
9597281	Apr 06, 2027	in 10 mo	U-674
9265720	Feb 25, 2031	in 4 yr 9 mo	U-674