The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Paclitaxel injection of strengths 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) multiple-dose vials.
