Drug application

PIZENSY (LACTITOL)

Drugs@FDA NDA 211281 · BRAINTREE LABS

Key facts

Drug name PIZENSY
Active ingredients LACTITOL
Application type NDA
Application number 211281
Company BRAINTREE LABS
Dosage forms FOR SOLUTION, ORAL
Strength 10GM
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Feb 12, 2020

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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