01 4BrightGene Bio-Medical Technology Co.,Ltd
02 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
03 1Xellia Pharmaceuticals ApS
01 3DALBAVANCIN HYDROCHLORIDE
02 1DALBAVANCIN HYDROCHLORIDE (DB)
03 1DALBAVANCIN PRECURSOR A40926
04 1DALBAVANCIN PRECURSOR A40926 (CBR48)
01 5China
02 1Denmark
01 6Active
01 4Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37185
Submission : 2022-09-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36025
Submission : 2021-08-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-25
Pay. Date : 2021-09-14
DMF Number : 35874
Submission : 2021-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-18
Pay. Date : 2022-12-12
DMF Number : 37186
Submission : 2022-11-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-01
Pay. Date : 2021-05-10
DMF Number : 35428
Submission : 2021-01-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-23
Pay. Date : 2024-01-29
DMF Number : 39378
Submission : 2024-03-27
Status : Active
Type : II
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