The approval is to market a generic equivalent of bactrim oral suspension, 200 mg/40 mg per 5 mL, of Sun Pharmaceutical Industries.
Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL, is indicated for the treatment and prevention of a wide variety of bacterial infections (such as middle ear, urine, respiratory, and intestinal infections), and certain type of pneumonia (pneumocystis-type).
According to the IQVIA MAT September 2020 data, Sulfamethoxazole and Trimethoprim Oral Suspension USP had estimated annual sales of approximately US $19 million in the US.
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