Aurobindo Receives FDA Approval for Zafirlukast Tablets, 10 mg and 20 mg
Published: November 27, 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 Zafirlukast Tablets, 10 mg and 20 mg. Aurobindo Pharma’s Zafirlukast Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Accolate Tablets manufactured by Strides Pharma Global Pte. Limited.
Zafirlukast Tablets are indicated for:
- The prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.