Drug application

CALCIUM DISODIUM VERSENATE (EDETATE CALCIUM DISODIUM)

Drugs@FDA NDA 008922 · BAUSCH

Key facts

Drug name CALCIUM DISODIUM VERSENATE
Active ingredients EDETATE CALCIUM DISODIUM
Application type NDA
Application number 008922
Company BAUSCH
Dosage forms INJECTABLE, INJECTION
Strength 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Jul 16, 1953

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

Browse all Drugs@FDA applications