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Aurobindo gets FDA approval for amoxicillin and clavulanate potassium for oral suspension

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EAST WINDSOR, N.J. — Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for amoxicillin and clavulanate potassium for oral suspension USP, 125 mg/31.25 mg per 5 mL and 250 mg/62.5 mg per 5 mL. Aurobindo’s amoxicillin and clavulanate potassium for oral suspension is an AB-rated generic equivalent to the reference listed drug, Neopharma’s Augmentin.

Amoxicillin and clavulanate potassium for oral suspension USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following:

  • Lower respiratory tract infections
  • Acute bacterial otitis media
  • Sinusitis
  • Skin and skin structure infections
  • Urinary tract infections


ECRM_06-01-22


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