01 1CKD Bio Corporation
02 2Chongqing DaXin Pharmaceutical
03 1Hangzhou Zhongmei Huadong Pharmaceutical
04 3Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
05 1Olon S.p.A
06 1Xellia Pharmaceuticals ApS
07 2Yacht Bio-Technology
08 2Zhejiang Hisun Pharmaceutical
09 1Zhejiang Medicine Co Ltd
01 11DAPTOMYCIN
02 1DAPTOMYCIN (PROCESS II)
03 1DAPTOMYCIN NON-STERILE
04 1DAPTOMYCIN, NON-STERILE, BULK DRUG
01 11China
02 1Denmark
03 1Italy
04 1South Korea
01 12Active
02 2Inactive
01 9Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-09-30
DMF Number : 29760
Submission : 2015-11-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-25
Pay. Date : 2019-08-26
DMF Number : 33671
Submission : 2019-09-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-04
Pay. Date : 2020-07-29
DMF Number : 34721
Submission : 2020-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-04
Pay. Date : 2017-09-20
DMF Number : 29859
Submission : 2015-09-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-21
Pay. Date : 2013-07-03
DMF Number : 22923
Submission : 2009-06-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-19
Pay. Date : 2013-06-25
DMF Number : 27179
Submission : 2013-07-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-28
Pay. Date : 2018-09-25
DMF Number : 33004
Submission : 2018-08-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30592
Submission : 2016-05-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2012-11-23
DMF Number : 26604
Submission : 2012-12-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-11
Pay. Date : 2013-01-09
DMF Number : 26778
Submission : 2013-01-07
Status : Active
Type : II
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