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List of Drug Master Files (DMF) of Aminophylline Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
26/09/2024 Roche Diagnostics GmbH
Germany
BOEHRINGER MANNHEIM GMBH 3966 AMINOPHYLLINE, HYDROUS (THEOPHYLLINE ETHYLENEDIAMINE, HYDROUS) 1980-09-26 Inactive II N/A
26/09/2024 Roche Diagnostics GmbH
Germany
BOEHRINGER MANNHEIM GMBH 3962 AMINOPHYLLINE,ANHYDROUS(THEOPHYLLINE ETHYLENEDIAMINE,ANHYDROUS) 1980-09-25 Inactive II N/A