FDA Approves LEUCOVORIN CALCIUM (ANDA207241)

The U.S. Food and Drug Administration (FDA) has approved the drug product LEUCOVORIN CALCIUM, identified by application number ANDA207241. LEUCOVORIN CALCIUM is a human prescription drug supplied as a solution for intramuscular and intravenous administration. The product contains 100 mg of calcium folinate base per 10 mL (equivalent to 10 mg per mL) and is marketed under the brand and generic name LEUCOVORIN CALCIUM. The NDC is 63323-631-10. The product is manufactured by Fresenius Kabi USA, LLC. The FDA submission was an original (ORIG) application, reviewed under standard priority, and received an approval status (AP) on March 14, 2018.