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List of Drug Master Files (DMF) of N-Butyl-6-Methylergoline-8-Carboxamide 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 Sandoz B2B
Switzerland
SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT 5944 6-METHYLERGOLINE-8B-CARBOXYLIC ACID 1985-07-17 Inactive II N/A
26/09/2024 Sandoz B2B
Switzerland
SANDOZ GMBH 5892 6-METHYLERGOLENE-8-CARBOXYLIC ACID 1985-06-03 Inactive II N/A