Orange Book product · Brand (NDA)

PRILOSEC OTC

OMEPRAZOLE MAGNESIUM

Brand (NDA)NDA 021229OTC ASTRAZENECA

View OMEPRAZOLE MAGNESIUM family Open on FDA Orange Book

At a glance

Jun 20, 2003

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jun 20, 2003
23 yr 4 mo ago
Today

Pharmaceutical detail

Active ingredient

OMEPRAZOLE MAGNESIUM

Strength

EQ 20MG BASE

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 021229

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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