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List of Drug Master Files (DMF) of methyl 2-phenyl-2-piperidin-2-ylacetate 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 Veranova
U.S.A
VERANOVA LP 10137 METHYLPHENIDATE HYDROCHLORIDE USP 1993-03-05 Active II N/A
26/09/2024 Noramco
U.S.A
NORAMCO LLC 22244 METHYLPHENIDATE HYDROCHLORIDE 2008-12-19 Active II Complete 2013-03-27 2012-11-23