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List of Drug Master Files (DMF) of Lercanidipine 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 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 35609 LERCANIDIPINE HYDROCHLORIDE (FORM-I) 2021-01-30 Active II N/A
26/09/2024 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 35507 LERCANIDIPINE HYDROCHLORIDE (AMORPHOUS) 2020-12-30 Active II N/A