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List of Drug Master Files (DMF) of (-)-3,4-Dihydroxy-alpha-((methylamino)methyl)benzyl alcohol 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 Transo-Pharm Handels GmbH
Germany
TRANSO PHARM HANDELS GMBH 30997 EPINEPHRINE/ ADRENALINE 2016-09-20 Active II Complete 2018-01-11 2016-12-28
26/09/2024 Amphastar Pharmaceuticals
U.S.A
AMPHASTAR NANJING PHARMACEUTICALS INC 33036 EPINEPHRINE USP 2018-08-08 Active II N/A