Orange Book product · Brand (NDA)

YOSPRALA

ASPIRIN; OMEPRAZOLE

Brand (NDA)NDA 205103DISCN GENUS LIFESCIENCES

Sep 14, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 14, 2016
9 yr 11 mo ago
Today
Patent 9987231 expires
Listed method-of-use patent (U-2324) expiration.
Jan 02, 2033
in 6 yr 8 mo
Patent 9539214 expires
Listed method-of-use patent (U-1902) expiration.
Mar 13, 2033
in 6 yr 10 mo

Active ingredient

ASPIRIN; OMEPRAZOLE

Strength

81MG;40MG

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 205103

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
9987231	Jan 02, 2033	in 6 yr 8 mo	U-2324
9539214	Mar 13, 2033	in 6 yr 10 mo	U-1902