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Guidance for Industry - Food and Drug Administration
The NDA/ANDA/AADA holder should follow the procedure outlined in Form FDA 2252 when filing an Annual Report. Annual Reports should be filed for all approved NDA's,[PDF]
Annual Report - Food and Drug Administration
1 2015 OGD ANNUAL REPORT | FDA’s Generic Drug Program FDA’S GENERIC DRUG PROGRAM Over the last several decades, the generic industry, the number of abbreviated new drug applications ,

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