Assyro AI

Orange Book product · Generic (ANDA)

PALIPERIDONE

PALIPERIDONE

Generic (ANDA)ANDA 202645DISCN ACTAVIS LABS FL INC

At a glance

Aug 03, 2015

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 03, 2015

    11 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

PALIPERIDONE

Strength

1.5MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 202645

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PALIPERIDONE

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.