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Orange Book product · Generic (ANDA)

AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Generic (ANDA)ANDA 217490TE ABRX ALKEM LABS LTD

At a glance

Jan 21, 2025

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 21, 2025

    1 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Strength

EQ 40MG MEDOXOMIL;12.5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 217490

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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.