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Aurobindo Receives FDA Approval for Ampicillin Capsules USP, 250 mg and 500 mg

Published: October 31, 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 Ampicillin Capsules USP, 250 mg and 500 mg. Aurobindo Pharma’s Ampicillin Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Principen Capsules manufactured by Apothecon Inc.

Ampicillin Capsules are indicated in the treatment of infections caused by susceptible strains of the designated organisms listed below:

  • INFECTIONS OF THE GENITOURINARY TRACT INCLUDING GONORRHEA: E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella, and nonpenicillinase producing N. gonorrhoeae
  • INFECTIONS OF THE RESPIRATORY TRACT: Nonpenicillinase- producing H. influenzae and staphylococci, and streptococci including streptococcus pneumonia
  • INFECTIONS OF THE GASTROINTESTINAL TRACT: Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci
  • MENINGITIS: N. Meningitides.