Haemonetics Manufacturing, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Anticoagulant Citrate Dextrose Solution A, USP

摘要

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) BA 710497/0 for Anticoagulant Citrate Dextrose Solution A, USP (ACD-A), In Plastic Bags, held by Haemonetics Manufacturing, Inc. Haemonetics Manufacturing, Inc., requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.