Drug application

PENTETATE ZINC TRISODIUM (PENTETATE ZINC TRISODIUM)

Drugs@FDA NDA 021751 · HAMELN PHARMA PLUS

Key facts

Drug name PENTETATE ZINC TRISODIUM
Active ingredients PENTETATE ZINC TRISODIUM
Application type NDA
Application number 021751
Company HAMELN PHARMA PLUS
Dosage forms SOLUTION, INHALATION, INTRAVENOUS
Strength EQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Aug 11, 2004

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

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:

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