Assyro AI

Orange Book product · Generic (ANDA)

IBANDRONATE SODIUM

IBANDRONATE SODIUM

Generic (ANDA)ANDA 203987DISCN AVET LIFESCIENCES

At a glance

Sep 02, 2014

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 02, 2014

    12 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

IBANDRONATE SODIUM

Strength

EQ 3MG BASE/3ML

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Not listed

Application

ANDA 203987

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of IBANDRONATE SODIUM

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.