Assyro AI

Orange Book product · Generic (ANDA)

ALENDRONATE SODIUM

ALENDRONATE SODIUM

Generic (ANDA)ANDA 090520TE AARX HIKMA

At a glance

Feb 25, 2013

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 25, 2013

    13 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ALENDRONATE SODIUM

Strength

EQ 70MG BASE/75ML

Dosage form

SOLUTION

Route

ORAL

TE code

AA

Application

ANDA 090520

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of ALENDRONATE 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.