Assyro AI

Orange Book product · Generic (ANDA)

EDETATE CALCIUM DISODIUM

EDETATE CALCIUM DISODIUM

Generic (ANDA)ANDA 216435RX CASPER PHARMA LLC

At a glance

May 03, 2023

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 03, 2023

    3 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

EDETATE CALCIUM DISODIUM

Strength

200MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 216435

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of EDETATE CALCIUM DISODIUM

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.