Assyro AI

Orange Book product · Generic (ANDA)

CELECOXIB

CELECOXIB

Generic (ANDA)ANDA 213301DISCN UNICHEM

At a glance

Jan 12, 2021

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 12, 2021

    5 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CELECOXIB

Strength

50MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 213301

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CELECOXIB

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.