Orange Book product · Brand (NDA)

OMEPRAZOLE

Brand (NDA)NDA 209400OTC DEXCEL

Jul 05, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 05, 2017
9 yr 1 mo ago
Today
Patent 10076494 expires
Listed drug product patent expiration.
Dec 08, 2036
in 10 yr 8 mo
Patent 10835488 expires
Listed drug product patent expiration.
Dec 08, 2036
in 10 yr 8 mo

Active ingredient

OMEPRAZOLE

Strength

20MG

Dosage form

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 209400

Product number

001

Marketing status

OTC

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
10076494	Dec 08, 2036	in 10 yr 8 mo	Product
10835488	Dec 08, 2036	in 10 yr 8 mo	Product