Drug application

FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE)

Drugs@FDA ANDA 217608 · AUROBINDO PHARMA LTD

Key facts

Drug name FOSFOMYCIN TROMETHAMINE
Active ingredients FOSFOMYCIN TROMETHAMINE
Application type ANDA
Application number 217608
Company AUROBINDO PHARMA LTD
Dosage forms FOR SOLUTION, ORAL
Strength EQ 3GM BASE/PACKET
Marketing status Prescription
TE codes AA
Reference listed drug No
Latest submission status date Nov 14, 2025

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 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:

Browse all Drugs@FDA applications