Drug application

PREPOPIK (CITRIC ACID, MAGNESIUM OXIDE, SODIUM PICOSULFATE)

Drugs@FDA NDA 202535 · FERRING PHARMS INC

Key facts

Drug name PREPOPIK
Active ingredients CITRIC ACID, MAGNESIUM OXIDE, SODIUM PICOSULFATE
Application type NDA
Application number 202535
Company FERRING PHARMS INC
Dosage forms FOR SOLUTION, ORAL
Strength 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2012

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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