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Orange Book product · Generic (ANDA)

IBANDRONATE SODIUM

IBANDRONATE SODIUM

Generic (ANDA)ANDA 204222TE APRX APOTEX
View IBANDRONATE SODIUM familyOpen on FDA Orange Book

At a glance

Oct 16, 2015

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 16, 2015

    10 yr 10 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 204222

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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

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