FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: APPROVAL OF PREVIOUSLY WITHDRAWN NEW DRUG APPLICATION FOR WELLCOVORIN (LEUCOVORIN CALCIUM) TABLETS

WASHINGTON, Sept. 24 -- Food and Drug Administration has issued a notice called: Approval of Previously Withdrawn New Drug Application for WELLCOVORIN (Leucovorin Calcium) Tablets.

The notice was published in the Federal Register on Sept. 24 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing approval of the previously withdrawn new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, equivalent to (EQ) 5 milligrams (mg) base and EQ 25 mg base. FDA is initiating this action on the basis of new data and is required to publish notice of approval of an NDA for which the Agency had previously withdrawn approval.

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