Assyro AI

Orange Book product · Generic (ANDA)

RISPERIDONE

RISPERIDONE

Generic (ANDA)ANDA 077953DISCN APOTEX INC

At a glance

Sep 15, 2008

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 15, 2008

    18 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

RISPERIDONE

Strength

0.25MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 077953

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of RISPERIDONE

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.