Assyro AI

Orange Book product · Brand (NDA)

LANSOPRAZOLE

LANSOPRAZOLE

Brand (NDA)NDA 208025OTC DEXCEL

At a glance

Jun 07, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 07, 2016

    10 yr 2 mo ago

  2. Today

  3. Patent 11077055 expires

    Listed drug product patent expiration.

    Apr 21, 2036

    in 10 yr

  4. Patent 11986554 expires

    Listed drug product patent expiration.

    Apr 21, 2036

    in 10 yr

Pharmaceutical detail

Active ingredient

LANSOPRAZOLE

Strength

15MG

Dosage form

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 208025

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11077055Apr 21, 2036in 10 yr
Product
11986554Apr 21, 2036in 10 yr
Product
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.