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In this section: Development & Approval Process (CBER)

2017 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes.

2017 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
Tradename	Indication for Use	NDA Number	Applicant	Approval Date

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