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You searched for: Copyright Public domain Remove constraint Copyright: Public domain Subjects United States. Department of Health and Human Services. Remove constraint Subjects: United States. Department of Health and Human Services. Genre Technical Report Remove constraint Genre: Technical Report Titles ANDA submissions--amendments to abbreviated new drug applications under GDUFA Remove constraint Titles: ANDA submissions--amendments to abbreviated new drug applications under GDUFA Start Over

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Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):
Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.