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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 Apac Pharmaceutical
U.S.A
APAC PHARMACEUTICAL LLC 28587 DYCLONINE HYDROCHLORIDE USP 2015-02-18 Active II Complete 2017-04-24 2015-06-08
28/10/2024 ChemPacific Corp
U.S.A
CHEMPACIFIC CORP 19497 DYCLONINE HYDROCHLORIDE DRUG SUBSTANCE 2006-03-31 Active II N/A