Assyro AI

Orange Book product · Generic (ANDA)

NILUTAMIDE

NILUTAMIDE

Generic (ANDA)ANDA 207631RX ANI PHARMS

At a glance

Jul 15, 2016

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 15, 2016

    10 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NILUTAMIDE

Strength

150MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 207631

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of NILUTAMIDE

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.