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Actual: Trade Name Emend (generic drugs available since ) ; Drug Products New Drug Application (NDA). New Drug Application (NDA). Abbreviated New Drug
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New Drug Approvals. All News Consumer Pro; New Drugs Subscribe to our newsletter for the latest medication news, new drug approvals and FDA alerts.

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FDA Requirements for New Drugs and Biologics. Investigational new drug (IND) means a new drug or biological drug that is used in a clinical investigation. The

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This guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their new drug

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FDA Requirements for New Drugs and Biologics Investigational new drug (IND) means a new drug or biological drug that is used in a clinical investigation.

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New Drug Application Type The type of new drug application approval. New Drug Applications (NDA or innovator) are N . Abbreviated New Drug Applications (ANDA or generic) are A .

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