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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
28/03/2025 Boehringer Ingelheim GmbH
Germany
BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG 5441 HOMATROPINE METHYLBROMIDE 1984-05-24 Inactive II N/A
28/03/2025 C-Squared Pharma
Ireland
C-SQUARED PHARMA LTD 31086 HOMATROPINE METHYLBROMIDE USP 2016-12-16 Active II Complete 2017-05-15 2017-01-03