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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
29/07/2025 ALP Pharm
China
ALP PHARM BEIJING CO LTD 37654 ISTRADEFYLLINE 2022-10-29 Active II N/A
29/07/2025 Kyowa Kirin
Japan
KYOWA HAKKO KIRIN CO LTD 23936 ISTRADEFYLLINE (KW-6002) DRUG SUBSTANCE 2010-07-01 Inactive II N/A