Assyro AI

Orange Book product · Generic (ANDA)

OLANZAPINE

OLANZAPINE

Generic (ANDA)ANDA 209399DISCN JIANGSU HANSOH PHARM

At a glance

Sep 24, 2018

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 24, 2018

    7 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

OLANZAPINE

Strength

2.5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 209399

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of OLANZAPINE

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.