Assyro AI

Orange Book product · Generic (ANDA)

QUETIAPINE FUMARATE

QUETIAPINE FUMARATE

Generic (ANDA)ANDA 078679DISCN CHARTWELL RX

At a glance

Dec 14, 2012

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 14, 2012

    13 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

QUETIAPINE FUMARATE

Strength

EQ 25MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 078679

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of QUETIAPINE FUMARATE

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.