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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 ChemWerth Inc
U.S.A
CHEMWERTH INC 19552 NICARDIPINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE 2006-06-26 Active II N/A
28/10/2024 Apothecon Pharmaceuticals
India
NAVINTA LLC 19773 NICARDIPINE HYDROCHLORIDE USP 2006-09-15 Active II Complete 2020-10-05 2020-09-29