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Start Over Subjects Investigational New Drug Application ✖Remove constraint Subjects: Investigational New Drug Application Subjects Humans ✖Remove constraint Subjects: Humans Subjects Drugs, Generic -- standards ✖Remove constraint Subjects: Drugs, Generic -- standards Titles ANDA submissions--amendments to abbreviated new drug applications under GDUFA ✖Remove constraint Titles: ANDA submissions--amendments to abbreviated new drug applications under GDUFA Languages English ✖Remove constraint Languages: English Genre Guideline ✖Remove constraint Genre: Guideline Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later

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  • ANDA submissions--amendments to abbreviated new drug applications under GDUFA1