Assyro AI

Orange Book product · Generic (ANDA)

CARGLUMIC ACID

CARGLUMIC ACID

Generic (ANDA)ANDA 213395TE ABRX NAVINTA LLC

At a glance

Jun 22, 2022

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 22, 2022

    4 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CARGLUMIC ACID

Strength

200MG

Dosage form

TABLET, FOR SUSPENSION

Route

ORAL

TE code

AB

Application

ANDA 213395

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CARGLUMIC ACID

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.