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List of Drug Master Files (DMF) of Restasis Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 1,308Xls 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 AbbVie Inc
U.S.A
ABBVIE INC 13800 CYCLOSPORINE USP 1998-09-01 Active II N/A
26/09/2024 Apotex Pharmachem
Canada
APOTEX PHARMACHEM INC 13929 CYCLOSPORINE USP (BULK) 1999-01-04 Active II Complete 2014-11-11 2014-05-08