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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 Veranova
U.S.A
VERANOVA LP 27700 DIPHENOXYLATE HCL 2014-01-20 Active II Complete 2015-09-03 2013-11-19
28/03/2025 Mallinckrodt Pharmaceuticals
Ireland
SPECGX LLC 12441 DIPHENOXYLATE HYDROCHLORIDE USP 1997-03-31 Active II Complete 2014-05-22 2014-03-05