Hospira, Inc., et al.; Withdrawal of Approval of One New Drug Application and Two Abbreviated New Drug Applications

摘要

The Food and Drug Administration (FDA) is withdrawing approval of one new drug application (NDA) and two abbreviated new drug applications (ANDAs) for edetate disodium injection. The holders of these applications have agreed in writing to permit FDA to withdraw approval of the applications and have waived their opportunity for a hearing.