Assyro AI

Orange Book product · Generic (ANDA)

DIFLUNISAL

DIFLUNISAL

Generic (ANDA)ANDA 074604DISCN ANI PHARMS

At a glance

Jun 10, 1996

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 10, 1996

    30 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DIFLUNISAL

Strength

500MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 074604

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DIFLUNISAL

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.