Drug application

SELENIOUS ACID (SELENIOUS ACID)

Drugs@FDA NDA 209379 · AM REGENT

Key facts

Drug name SELENIOUS ACID
Active ingredients SELENIOUS ACID
Application type NDA
Application number 209379
Company AM REGENT
Dosage forms SOLUTION, INTRAVENOUS
Strength EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)
Marketing status Prescription
TE codes AP
Reference listed drug Yes
Latest submission class Type 2 - New Active Ingredient
Latest submission status date Apr 30, 2019

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 1–9 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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