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List of Drug Master Files (DMF) of 1(2H)-Phthalazinone hydrazone hydrochloride Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 216Xls download

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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 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 34452 HYDRALAZINE HYDROCHLORIDE USP 2019-12-24 Active II Complete 2020-07-02 2020-03-05
26/09/2024 Apothecon Pharmaceuticals
India
NAVINTA LLC 24321 HYDRALAZINE HYDROCHLORIDE USP (P) GRADE 2010-10-28 Active II N/A