01 1Olon S.p.A
02 1Blank
01 2PRALSETINIB
01 1Italy
02 1Blank
01 2Active
01 2Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-06-14
Pay. Date : 2024-05-20
DMF Number : 39659
Submission : 2024-05-24
Status : Active
Type : II
USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2024-06-26
Pay. Date : 2024-06-17
DMF Number : 39814
Submission : 2024-04-15
Status : Active
Type : II
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