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Aurobindo Receives FDA Approval for Nitrofurantoin Oral Suspension USP, 25 mg/5 mL

Published: May 11, 2023

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Nitrofurantoin Oral Suspension USP, 25 mg/5 mL. Aurobindo Pharma’s Nitrofurantoin Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), Furadantin® Oral Suspension manufactured by Casper Pharma LLC.

Nitrofurantoin Oral Suspension are indicated for:

  • The treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.