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

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$ API Ref.Price (USD/KG) : 700Xls 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 FARMAK, a.s
Czech Republic
FARMAK AS 15525 TIZANIDINE HCL 2001-07-04 Active II Complete 2015-03-03 2014-10-14
26/09/2024 Dr. Reddy\\\'s Laboratories
India
DR REDDYS LABORATORIES LTD 15699 TIZANIDINE HYDROCHLORIDE USP 2001-11-02 Active II Complete 2014-01-23 2013-04-12