Drug application

SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID (CITRIC ACID, MAGNESIUM OXIDE, SODIUM PICOSULFATE)

Drugs@FDA ANDA 212789 · HETERO LABS LTD V

Key facts

Drug name SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Active ingredients CITRIC ACID, MAGNESIUM OXIDE, SODIUM PICOSULFATE
Application type ANDA
Application number 212789
Company HETERO LABS LTD V
Dosage forms FOR SOLUTION, ORAL
Strength 12GM/PACKET;3.5GM/PACKET;10MG/PACKET
Marketing status Prescription
Reference listed drug No
Latest submission status date Jul 18, 2022

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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