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List of Drug Master Files (DMF) of Ketoconazole 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 Nuray Chemicals Private Limited
India
SS PHARMA LLC 38417 KETOCONAZOLE USP 2023-07-15 Active II Complete 2023-08-23 2023-05-26
26/09/2024 Derivados Quimicos SAU
Spain
DERIVADOS QUIMICOS SAU 14794 KETOCONAZOLE 2001-01-19 Active II N/A