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List of Drug Master Files (DMF) of Hyoscine N-Butyl Bromide 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
28/10/2024 Boehringer Ingelheim GmbH
Germany
BOEHRINGER INGELHEIM PHARMA KG 11679 SCOPOLAMINE-N-BUTLYBROMIDE (BUSCOPAN) 1995-09-20 Inactive II N/A
28/10/2024 Vital Laboratories Private Limited
India
VITAL LABORATORIES PVT LTD 24477 SCOPOLAMINE BUTYL BROMIDE (HYOSCINE BUTYL BROMIDE) 2010-10-01 Active II N/A