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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 | KANEKA AMERICA CORP |
U.S.A |
KANEKA AMERICA CORP | 14955 | N-2-[1-(S)-ETHOXYCARBONYL]-N-6-TRIFLUOROACETYL-1-LYSYL-N-2-CARBOXY ANHYDRIDE(EPTL) | 2000-09-19 | Inactive | II | N/A | ||
28/03/2025 | Kaneka Corporation |
Japan |
KANEKA CORP | 7995 | N-[1(S)-ETHOXYCARBONYL-3-PHENYLPROPYL]-L-ALANYL-N-CARBOXY ANHYDRIDE | 1989-03-22 | Inactive | II | N/A |