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List of Drug Master Files (DMF) of Hypromellosum 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 SHIN-ETSU
Germany
SHIN-ETSU CHEMICAL CO LTD 3748 PHARMACOAT AND METOLOSE (LOW DEGREE OF POLYMERIZATION) METOLOSE (HIGH DEGREE OF POLYMERIZATION) 1980-03-10 Active IV N/A
26/09/2024 Shin-etsu Chemical
Japan
SHIN-ETSU CHEMICAL CO LTD 35374 METOLOSE VF GRADES 2020-11-09 Active IV N/A