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List of Drug Master Files (DMF) of COLESTIPOL 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 Formosa Laboratories
Taiwan
FORMOSA LABORATORIES INC 17651 COLESTIPOL HYDROCHLORIDE 2004-09-02 Active II Complete 2020-09-29 2020-09-22
26/09/2024 Raks Pharma
India
RAKS PHARMA PVT LTD 38026 COLESTIPOL HYDROCHLORIDE USP 2023-02-24 Active II Complete 2023-03-08 2023-02-15