FDA Approves ANDA 088371 for Baxter Cyclophosphamide Injection

The U.S. Food and Drug Administration (FDA) has granted approval for ANDA 088371, an abbreviated new drug application for a cyclophosphamide injection product. The product is listed as an injectable dosage form containing 100 mg of cyclophosphamide per vial. The product, identified under brand name Cyclophosphamide with product number 001, is not a reference drug and its marketing status is noted as discontinued. It is manufactured by Baxter Healthcare. The approval follows a series of supplemental submissions covering manufacturing (CMC) and labeling. Notable submissions include manufacturing submissions (numbers 4, 8, 10, 11, 13) and labeling submissions (numbers 7, 9, 12, 14), all of which received an approved (AP) status on dates ranging from May 13, 1988 to May 7, 1991. Baxter Healthcare, the sponsor, submitted the original application on July 3, 1986, which also received approval. The comprehensive submission history reflects the FDA’s review of both the product’s manufacturing processes and labeling information.