Caplin Steriles Gets USFDA approval for Milrinone Lactate In 5% Dextrose Injection, Infusion Bags
Caplin Steriles Limited has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL (0.2 mg/mL) and 40 mg/200 mL (0.2 mg/mL) Single-dose Infusion Bags, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) PRIMACOR in Dextrose 5%, by Sanofi Aventis US LLC.