Assyro AI

Orange Book product · Generic (ANDA)

IRBESARTAN

IRBESARTAN

Generic (ANDA)ANDA 200832DISCN APOTEX INC

At a glance

Oct 15, 2012

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 15, 2012

    13 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

IRBESARTAN

Strength

75MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 200832

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of IRBESARTAN

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.