Assyro AI

Orange Book product · Generic (ANDA)

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Generic (ANDA)ANDA 077528TE ABRX TEVA PHARMS

At a glance

Jun 19, 2012

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 19, 2012

    14 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Strength

EQ 50MG BASE;EQ 6MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 077528

Product number

003

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of FLUOXETINE HYDROCHLORIDE; 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.