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List of Drug Master Files (DMF) of Nilotinib Hydrochloride 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 Sichuan Elixir Pharmaceuticals
China
SICHUAN ELIXIR PHARMACEUTICAL CO LTD 39648 NILOTINIB 2024-03-27 Active II N/A
26/09/2024 Granules India Limited
India
GRANULES INDIA LTD (UNIT-V) 37531 NILOTINIB HYDROCHLORIDE MONOHYDRATE 2022-09-30 Active II N/A