Assyro AI

Orange Book product · Generic (ANDA)

IBANDRONATE SODIUM

IBANDRONATE SODIUM

Generic (ANDA)ANDA 206058TE APRX ACCORD HLTHCARE

At a glance

Feb 05, 2016

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 05, 2016

    10 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

IBANDRONATE SODIUM

Strength

EQ 3MG BASE/3ML

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

AP

Application

ANDA 206058

Product number

001

Marketing status

RX

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.