Orange Book product · Brand (NDA)

ZEGERID OTC

OMEPRAZOLE; SODIUM BICARBONATE

Brand (NDA)NDA 022281OTC RILEY CONSUMER

View OMEPRAZOLE; SODIUM BICARBONATE family Open on FDA Orange Book

At a glance

Dec 01, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 01, 2009
16 yr 9 mo ago
Today

Pharmaceutical detail

Active ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Strength

20MG;1.1GM

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 022281

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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