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DR 4500.9RDEFENSE TRANSPORTATION REGULATION ABBREVIATIONS & ACRONYMS1 March 2016Defense Transportation Regulation Abbreviations & Acronyms1 March 2016DTR ABBREVIATIONS & ACRONYMS NUMERALS 2D 3PLTwo
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Abbreviations Amp stands for Abbreviated New Drug Application, it is a submission to the US FDA for the approval of generic drugs.
Any company seeking to market a generic drug in the US is required to file an Abbreviated New Drug Application.
Abbreviated New Drug Applications must include information on the drug's formulation, manufacturing process, labeling, and bioequivalence to the brand-name drug.
The purpose of Abbreviated New Drug Applications is to demonstrate that a generic drug is bioequivalent to the brand-name drug and is therefore safe and effective for use.
Abbreviated New Drug Applications must include information on the drug's active ingredients, labeling, manufacturing process, and bioequivalence testing.
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