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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
28/03/2025 Shandong Chenghui Shuangda Pharmaceutical
China
SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO LTD 37519 PRAMOXINE HYDROCHLORIDE 2022-09-15 Active II N/A
28/03/2025 Cyalume Specialty Products
U.S.A
FAR SPECIALTY PRODUCTS INC DBA FAR CHEMICAL 19915 PRAMOXINE HYDROCHLORIDE USP 2006-11-01 Active II N/A