Various Drug Applications INDA- Investigational New Drug Application NDA- New Drug Application ANDA- Abbreviated New Drug Application SNDA-
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As the dynamic global drug abuse situation is increasingly characterized by the appearance of new drugs and/or new marketing concepts for drugs, these new
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New drug entities (including new generics and new drug product dosage forms of existing drug entities) will be identified weekly and
As the dynamic global drug abuse situation is increasingly characterized by the appearance of new drugs and/or new marketing concepts for drugs, these new
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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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