Abbott's ritodrine HCl
Executive Summary
Firm's petition for ANDA suitability of ritodrine HCl 150 mg (0.3 mg/ml) in 5% dextrose injection, 500 ml containers, approved by FDA. The reference drug is Astra's Yutopar (ritodrine) sterile solution (for dilution) 15 mg/ml in 10 ml vials.