Orange Book product · Brand (NDA)

OMEPRAZOLE

Brand (NDA)NDA 022032OTC DEXCEL PHARMA

Dec 04, 2007

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 04, 2007
18 yr 10 mo ago
Today
Patent 12599565 expires
Listed drug product patent expiration.
Jan 31, 2030
in 3 yr 8 mo

Active ingredient

OMEPRAZOLE

Strength

20MG

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 022032

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
12599565	Jan 31, 2030	in 3 yr 8 mo	Product