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List of Drug Master Files (DMF) of [1-(1-adamantyl)ethyl]amine hydrochloride 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 Olpha
Latvia
OLAINFARM JSC 15210 RIMANTADINE HYDROCHLORIDE 2000-12-21 Active II Complete 2014-06-17 2012-11-27
26/09/2024 Cilag AG
Switzerland
CILAG AG 10233 RIMANTADINE HYDROCHLORIDE 1993-05-05 Inactive II N/A