Assyro AI

Orange Book product · Generic (ANDA)

DEXLANSOPRAZOLE

DEXLANSOPRAZOLE

Generic (ANDA)ANDA 202294TE ABRX PH HEALTH

At a glance

Jun 16, 2022

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 16, 2022

    4 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXLANSOPRAZOLE

Strength

30MG

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 202294

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DEXLANSOPRAZOLE

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.

Agent CTA Background

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