Assyro AI

Orange Book product · Generic (ANDA)

ALENDRONATE SODIUM

ALENDRONATE SODIUM

Generic (ANDA)ANDA 206387TE ABRX IPCA LABS LTD

At a glance

Jun 04, 2024

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 04, 2024

    2 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ALENDRONATE SODIUM

Strength

EQ 10MG BASE

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 206387

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

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.