01 2BrightGene Bio-Medical Technology Co.,Ltd
02 1North China Pharmaceutical Huasheng Co Ltd
01 2FIDAXOMICIN
02 1FIDAXOMICIN CRYSTALLINE
01 3China
01 3Active
01 3Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-25
Pay. Date : 2014-11-24
DMF Number : 28803
Submission : 2014-11-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-04
Pay. Date : 2023-09-20
DMF Number : 38815
Submission : 2023-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-04
Pay. Date : 2015-09-22
DMF Number : 29374
Submission : 2015-09-29
Status : Active
Type : II
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