Drug application

SODIUM PHENYLBUTYRATE (SODIUM PHENYLBUTYRATE)

Drugs@FDA ANDA 090910 · ALVOGEN

Key facts

Drug name SODIUM PHENYLBUTYRATE
Active ingredients SODIUM PHENYLBUTYRATE
Application type ANDA
Application number 090910
Company ALVOGEN
Dosage forms TABLET, ORAL
Strength 500MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Nov 18, 2011

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No 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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