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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
24/02/2025 Kyowa Kirin
Japan
KYOWA HAKKO KIRIN CO LTD 23936 ISTRADEFYLLINE (KW-6002) DRUG SUBSTANCE 2010-07-01 Inactive II N/A
24/02/2025 MSN Laboratories
India
MSN LIFE SCIENCES PRIVATE LTD 38721 ISTRADEFYLLINE 2023-09-29 Active II N/A