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List of Drug Master Files (DMF) of Norepinephrine Bitartrate 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 Cambrex Corporation
U.S.A
CAMBREX PROFARMACO MILANO SRL 12037 NOREPINEPHRINE BITARTRATE/NORADRENALINE TARTRATE 1996-07-10 Active II Complete 2013-09-21 2013-09-11
26/09/2024 ChemPacific Corp
U.S.A
CHEMPACIFIC CORP 16344 NOREPINEPHRINE BITARTRATE 2002-12-20 Active II Complete 2014-01-03 2013-12-20